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Experts: Device Industry May See Fewer Patent Suits

March 19, 2008

The medical device industry may see fewer patent suits in the future as companies become smarter about when and what to patent, experts say. The device industry is a breeding ground for litigation, Nerac patent attorney Scott Lloyd said. He pointed out that companies often become the target of litigation by patenting or publishing something. As a result, many companies, particularly startups, are reluctant to patent in the initial phase of product development, Lloyd said during a pod cast by Nerac, an advisory firm. These companies may think they do not have the resources to see the process through, or they may be concerned about what technology will come from competitors who also are reluctant to publish, he said. Unlike in the pharmaceutical industry where companies patent particular compounds, there are usually multiple ways to arrive at a functional device, David Hsu, a management professor at the University of Pennsylvania, said.

Device Companies Will Be Under FCPA Spotlight, Experts Say

March 18, 2008

Medical device companies can expect to be increasingly under the gun in Foreign Corrupt Practices Act (FCPA) investigations, experts warn. Although the focus of these investigations has been mostly on pharmaceutical companies, medical device makers have increasingly found themselves the subject of “sweep cases,” where the SEC “checks the tires of industries,” Michael Horowitz, partner at law firm Cadwalader, Wickersham & Taft, said. James Ravitz, a partner in Arent Fox’s healthcare practice group, agreed that as the device industry becomes more global, FCPA investigations will increase. He said it will be interesting to see whether these will be stand-alone actions or if they will be combined with other investigations. “For large device companies with global operations, I think we’re going to see more cases where FCPA investigations are added as a cause of action to other investigations,” Ravitz said. For example, shortly after Stryker resolved a Department of Justice investigation into its consulting practices — part of an industry wide investigation of orthopedic firms — the company announced an SEC inquiry and subpoena regarding possible FCPA violations

Industry Wants EU Incentives for Orphan Devices, Diagnostics

March 13, 2008

The European Commission should offer incentives for research on medical devices for rare diseases similar to the ones it provides for orphan medicines, an industry group says. In its comments on a public consultation on rare diseases, Eucomed also says it would be appropriate to analyze the current requirements set forth in Directives 90/385/EEC and 93/42/EEC for custom-made devices and in Article 11.13 for compassionate use devices. While these requirements allow nonmass-produced devices to be marketed without a full conformity assessment, implementation is left to individual European Union (EU) member states, resulting in a lack of harmonization and uneven access to diagnosis and treatment, Eucomed says. An orphan regulation on devices and diagnostics also would help address the fragmented tracking of diagnoses of rare diseases, the group adds. Eucomed recommends broadening the definition of rare diseases to encompass patients with more common diseases who have exhausted standard therapeutic options. “Such patients with severely impaired health status may eventually profit from extracorporeal therapy (‘last resort’ option),” Eucomed says. The commission plans to publish a communication on a “European Action in the Field of Rare Diseases” in November 2008. The public consultation, “Rare Diseases: Europe’s Challenges,” is available at ec.europa.eu/health/ph_threats/non_com/docs/raredis_comm_draft.pdf.

UK’s MHRA Calls for Quicker Clinical Trial Safety Reporting

March 10, 2008

The European Commission should offer incentives for research on medical devices for rare diseases similar to the ones it provides for orphan medicines, an industry group says. In its comments on a public consultation on rare diseases, Eucomed also says it would be appropriate to analyze the current requirements set forth in Directives 90/385/EEC and 93/42/EEC for custom-made devices and in Article 11.13 for compassionate use devices. While these requirements allow nonmass-produced devices to be marketed without a full conformity assessment, implementation is left to individual European Union (EU) member states, resulting in a lack of harmonization and uneven access to diagnosis and treatment, Eucomed says. An orphan regulation on devices and diagnostics also would help address the fragmented tracking of diagnoses of rare diseases, the group adds. Eucomed recommends broadening the definition of rare diseases to encompass patients with more common diseases who have exhausted standard therapeutic options. “Such patients with severely impaired health status may eventually profit from extracorporeal therapy (‘last resort’ option),” Eucomed says. The commission plans to publish a communication on a “European Action in the Field of Rare Diseases” in November 2008. The public consultation, “Rare Diseases: Europe’s Challenges,” is available at ec.europa.eu/health/ph_threats/non_com/docs/raredis_comm_draft.pdf.

Investigations of Adverse Device Events in UK Take Less Time

February 2, 2008

Medical device companies being investigated in the UK this past year for adverse events spent less time under the microscope, especially those undergoing an in-depth investigation. Half of the standard investigations of adverse incidents involving medical devices in 2007 were completed within 12 weeks, according to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In 2006, it took up to three weeks longer to wrap up standard investigations, which are conducted by the companies themselves, for nearly 50 percent of the cases. The shorter time frame was largely due to “the parallel completion of a large number of related investigations arising from numerous reports of a particular problem with a particular device,” the MHRA says in a January device bulletin. The bulletin also offers updated guidance on reporting and disseminating information about device-related adverse events. It includes requirements on the quarantine, labeling and storage of equipment involved in such incidents.

Thousands of Sponsors Rush to Register With ClinicalTrials.gov

January 22, 2008

Recent weeks have seen a stampede of clinical trial sponsors or other “responsible parties” newly registering 1,944 studies and updating 12,132 existing entries in ClinicalTrials.gov, according to the NIH-sponsored registry’s chief architect, Nicholas Ide. But thousands more apparently are not in compliance with the FDA Amendments Act (FDAAA) of 2007, which requires the sponsors or designated responsible parties of all clinical trials, except Phase I trials and small feasibility studies of devices, to register a range of information on ClinicalTrials.gov. The deadline was Dec. 26, 2007, for trials that were running as of Sept. 27, 2007, when President Bush signed FDAAA into law.

FDA Issues Final Guidance on the Review of Manufacturing Information in PMAs

January 16, 2008

The FDA is clarifying the type of data submitted with 180-day supplements to premarket approval applications (PMAs) in a new guidance document. Such supplements are submitted when manufacturers have a significant change to an approved device. The guidance, “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,” details the FDA review of manufacturing sections in PMAs as well as procedures the agency uses to determine whether facilities will be inspected after the submission of such filings. The guidance was published Jan. 8 in the Federal Register. “In most cases, only new preclinical testing is needed to demonstrate reasonable assurance of safety and effectiveness of the modified device. In some instances, however, limited confirmatory clinical data may be necessary to provide a bridge between the clinical data set for the original device and the expected clinical performance of the modified device,” the guidance says. The guidance does not change the types of device modifications that may require 180-day supplements — such as changes to principles of operation, control mechanism, labeling, design and performance and testing requirements or acceptance criteria. Comments to the final guidance can be submitted to the FDA at any time.

eMDR Reporting to be Made Mandatory ... Are You Ready and Prepared for This New Mandate?

December 10, 2007

In order to maintain brand perception, medical device companies must juggle quick resolution of customer complaints along with regulatory compliance and corporate objectives. Besides being necessary for maintaining compliance, complaint handling is an essential element for improving a company’s performance. Medical device manufacturers are required to submit mandatory 3500A Medwatch reports when their devices are involved in patient safety issues or product malfunctions. The FDA receives more than 300,000 reports annually, of which all are entered manually into its adverse event databases. The FDA is urging device manufacturers to voluntarily adopt the agency’s electronic medical device reporting (eMDR) process. The program, intended to help identify patterns in adverse events more easily and reduce the overwhelming number of paper reports, is currently optional. However, a draft rule mandating electronic reporting is being completed and is expected to become mandatory as early as spring 2008. Making the Move to Electronic Submissions Besides becoming a mandatory effort, there are many reasons why a manufacturer would want to begin electronically submitting its MDRs. First of all, by moving to an electronic submission, you eliminate the need to print paper reports and the cost to ship them (overnight, in many cases) to the FDA. You also avoid the cost of time and possible errors in double data entry to generate the correct reports needed. To begin electronic submissions, manufacturers must first register as a trading partner and then complete six tests. The tests are designed to mimic real-life electronic submissions, and the vendor must pass all six tests to use the system. Since this can be a time-consuming process, it is best to begin this process now, while it is still an optional process, so you can be prepared when the eMDR is mandatory. To avoid double data entry and make the process as easy as possible, manufacturers with more than 50 MDRs per month should consider an integrated software program that allows them to generate the correct report information in acceptable formats. This saves time and possible data entry errors, as well as reduces manpower necessary to submit reports. You also can track the submissions electronically and trend pass-fail submissions. This will allow you to streamline your processes while cutting costs and maintaining compliance. Overall, if the software manufacturer has worked closely with the FDA on the development of its solution, this will lead to reduced opportunities of any FDA warnings for timeliness and accuracy of data. Webinar: CDRH eMDR to be Made Mandatory. Are you Ready? Understand the new eMDR program and what you will need to know to implement mandatory electronic reporting in the near future. Click here to view the pre-recorded webinar.

GHTF Creating Ties With Asian, Latin American Countries

November 19, 2007

Future plans of the Global Harmonization Task Force (GHTF) include expanding the organization’s ties with other countries, especially those in Latin America and Asia. Speaking at the GHTF’s conference in Washington, D.C., Chairman Larry Kessler cited as a “measure of our success” recent partnerships with the Asian Harmonization Working Party and the Pan American Health Organization. The task force also met this past summer in Vietnam with members of the Association of Southeast Asian Nations, he said, adding that health ministers from the association’s member nations committed to align their regulatory frameworks with the GHTF by 2010. Discussion of the growing involvement of countries beyond the founding five (the U.S., Canada, the European Union, Japan and Australia), which have experienced recent growth in the device market, was a major theme of the three-day conference.

GHTF Creating Ties With Asian, Latin American Countries

November 16, 2007

Future plans of the Global Harmonization Task Force (GHTF) include expanding the organization’s ties with other countries, especially those in Latin America and Asia. Speaking at the GHTF’s conference in Washington, D.C., Chairman Larry Kessler cited as a “measure of our success” recent partnerships with the Asian Harmonization Working Party and the Pan American Health Organization. The task force also met this past summer in Vietnam with members of the Association of Southeast Asian Nations, he said, adding that health ministers from the association’s member nations committed to align their regulatory frameworks with the GHTF by 2010. Discussion of the growing involvement of countries beyond the founding five (the U.S., Canada, the European Union, Japan and Australia), which have experienced recent growth in the device market, was a major theme of the three-day conference.

Man Given Unusual Sentence for Making, Selling Medical Device

November 1, 2007

The owner of a Birmingham medical services firm will have to wear a tee shirt or a golf shirt bearing the inscription: “I WAS CONVICTED OF VIOLATING THE FDCA."

EU Members Barred From Creating Obstacles to Device Trials

October 29, 2007

The European Union (EU) is making it easier for medical practitioners to conduct device trials. A new amendment to the EU Clinical Trials Directive (CTD) prohibits EU member states from putting any obstacles in the way of medical practitioners qualified to conduct a device clinical trial getting hold of the investigational devices as long as they have satisfied all regulatory requirements. Anyone authorized to carry out a device trial by virtue of his or her professional qualifications “shall be accepted as equivalent to a duly qualified medical practitioner” for the purposes of the study, the amendment says. Clinical trials are required for new devices unless justification can be provided for relying on existing clinical data. “Clinical data is generally required for all devices regardless of classification and the possibility to centralize data on clinical investigations in the European databank,” the amendment states.

Multinational Device Trials Require Careful Forethought

October 20, 2007

Global clinical trials offer device sponsors a number of advantages, but unless they are planned carefully, the FDA may reject the data, according to experts speaking at last month’s annual meeting of the Regulatory Affairs Professionals Society. “Gain FDA acceptance for your clinical approach prior to initiating trials, and be sure you know well in advance what percentage of the data the FDA will accept,” Darrell DeMello, president of the eye therapy device company ScyFIX, said. Many factors are driving device companies to sponsor multinational trials. Because these firms tend to be smaller than drug companies, their resources tend to be more limited. “Cost factors are critical for us as a startup company,” DeMello said.

Guidance Helps Small Companies Get User Fee Discounts

October 20, 2007

An updated guidance document will help companies attempting to qualify as a small business under the Medical Device User Fee and Modernization Act (MDUFMA). The fiscal 2008 fee rates under MDUFMA that took effect Oct. 1 provide a 50 percent discount for small businesses on submissions other than 510(k) premarket notifications, 30-day notices and 513(g) requests for classification information. The guidance, which supersedes a 2006 version, covers: Benefits of qualifying as a small business; Guidance for U.S. businesses; Guidance for foreign businesses; Guidance for foreign governments; Frequently asked questions; and Forms and instructions. The document, “FY 2008 Medical Device User Fee Small Business Qualification and Certification,” can be seen at www.fda.gov/cdrh/mdufma/guidance/2008.pdf.

FDA Announces User Fees for Device Makers in 2008

October 17, 2007

The FDA has established its user fee rates for device makers in fiscal 2008 under the Medical Device User Fee and Modernization Act (MDUFMA). The fee rates, which went into place Oct. 1, will remain effective through Sept. 30, 2008. The law reauthorizing MDUFMA includes two new types of fees intended to generate approximately 50 percent of the total fee revenue — an annual establishment registration fee and an annual fee for filing periodic reports on Class III devices. User fees also will be charged for medical device submissions. Under the act, the fee rate for each type of submission is set at a specified percentage of the standard fee for a premarket application, a product development protocol or a biologics licensing application. The standard fee for a premarket application received by the FDA during fiscal 2008 is $185,000, the agency said.

Stem Cell Therapy in ‘Transition Period’ Benefiting Devicemakers

October 12, 2007

Advanced therapies using cells are being commercialized rapidly and are transitioning from development to implementation, a trend that will work in favor of the medical device industry, Cytonome President Lydia Villa-Komaroff said. A number of trials have indicated cell therapy will be an effective treatment, and one analyst has predicted the cell therapy market will be worth $8.5 billion by 2016, Villa-Komaroff added, speaking at AdvaMed 2007. Cell therapy is in a transition period, shifting from development to more practical issues of implementation, and medical devicemakers have a critical role to play in this transition, she said. The medical device industry touches every part of the process for these therapies, from cell extraction to therapy evaluation, she said, adding that the industry is uniquely qualified to lower the risks and advance the practice of cellular medicine.

From ‘Star Trek’ to Your Doctor: Small Scanners Appear

October 11, 2007

What if your doctor could swipe a wand over your neck and reveal whether you have hidden heart disease? That is now possible in places other than the sickbay of the starship Enterprise.

Bush Signs Bill to Maintain Funding While Budget Work Continues

October 11, 2007

President Bush signed a bill into law that will continue government funding through Nov. 16, giving Congress more time to finish work on the fiscal 2008 federal budget. The fiscal year ended Oct. 1. Failure to pass the bill would have left the government with no money to function. “Congress failed in its most basic responsibility,” President Bush said in his weekly radio address, noting that Congress did not submit any of the 12 spending bills to him before the fiscal year ended. Bush has threatened to veto many of the bills because of increases in spending levels, including one that would provide $1.69 billion to the FDA in fiscal 2008. Congress has “chosen the path of higher spending,” proposing increases that would add $205 billion more than the administration’s budget request over the next five years, Bush said. The House passed H.J. Res. 52 to continue funding by a 404-14 vote Sept. 26; the bill passed the Senate 94-1 Sept. 27. H.J. Res. 52 can be seen at thomas.loc.gov/cgi-bin/bdquery/z?d110:H.J.RES.52:.

Lawyer Warns Against Getting Too Comfortable With Industry Practices

October 9, 2007

Although there have not been as many fraud and abuse cases against device makers as pharmaceutical companies, there is an emerging focus on device makers — sometimes on common industry practices — according to Barbara Ryland, an attorney with law firm Crowell & Moring. The pharmaceutical industry is probably five or 10 years ahead, but this area is evolving when it comes to device manufacturers, Ryland said at AdvaMed 2007. She discussed a $310 million civil settlement announced last month between five orthopedic companies and the U.S. attorney for the District of New Jersey. The settlement followed an industry wide investigation into sales practices.

Medical Device Companies on Defense

October 5, 2007

Medical device companies are on defense to prove their pricey new technologies are worth the price, in the face of increasing U.S. health care costs and rising numbers of individuals without health insurance.

Bush Signs MDUFMA Reauthorization Bill Into Law

October 2, 2007

President Bush signed the FDA Amendments Act, H.R. 3580, into law Sept. 27, reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA) and granting the FDA additional authority. FDA Commissioner Andrew von Eschenbach said in an FDA conference call that the timing of the law’s passage is important as it eliminates the possibility of reductions in the agency work force. Reauthorization of MDUFMA will provide, in addition to appropriated funds, a revenue of $287 million by October 2012, Randall Lutter, the agency’s deputy commissioner for policy, said. The reauthorization will ensure that the FDA centers have the resources needed to conduct complex and comprehensive reviews of new devices, von Eschenbach said. The user fee programs reauthorized under the law account for nearly a quarter of the FDA’s total budget, Lutter said. The act streamlines the inspection program by allowing outside firms to inspect for good manufacturing practices so the FDA can focus its resources on high-risk products and facilities. FDA Deputy Commissioner Janet Woodcock said pediatric provisions in the law will help the agency determine whether children would benefit from devices. The act calls for the FDA to track and report to Congress on the number and types of devices approved specifically for pediatric conditions “so we can all get a better handle on this,” she said. The FDA also will report to Congress on approval times for devices on the market for children.

Report: Proceed With Caution Into Chinese Device Market

September 27, 2007

Devicemakers should be mindful of the barriers and growth inhibitors of China’s implantable cardiac device market before “unrealistic expectations about the near-term business opportunity in China lead to disappointment,” according to a new white paper from research firm Emerging Asia. The paper, “Implantable Cardiac Devices in China,” recommends a cautious approach and advises manufacturers to consider the barriers before committing to a large investment in entering the market. The Chinese market for high-end medical devices is expanding rapidly, but it remains small in comparison to developed markets because of outdated medical facilities, the inability of the majority of Chinese to afford treatment and corruption in the distribution and sales channels, the paper says. While the findings are drawn from a study of implantable cardiac devices, they are applicable to other high-end medical devices.

AdvaMed Working With China to Improve Oversight of Medical Devices

September 26, 2007

Industry association AdvaMed is taking a proactive role — meeting with Chinese and U.S. healthcare officials — to ensure that medical devices and device components imported from China pose no risks to the U.S. public, AdvaMed said in a recent conference call. The focus is on creating training programs for Chinese regulators and encouraging the government to adopt global guidelines and standards for its regulatory systems, Ralph Ives, executive vice president for global strategy and analysis, said in the Sept. 18 international conference call. “The best effort is on training regulatory [personnel] in any country on the most effective regulatory practices,” he added. Chinese products have been scrutinized since a spate of publicized food and toy recalls earlier this year. Although no problems have been found in medical devices, Ives said the fact that China exports approximately $2.4 billion in medical devices to the U.S. each year makes the issue worth following closely.

Pending FDA Legislation Mandates Unique IDs for Medical Devices

September 25, 2007

The bill to mandate unique IDs for medical devices is expected to be signed into law as a part of a Food and Drug Administration bill currently making its way to President Bush's desk. The requirement, contained in the Medical Device User Fee and Modernization Act portion of the FDA Amendments Act of 2007, would enable universal tracking and easier location of products in the case of a recall, say supporters of the provision. It would also allow hospitals to better compare products in specific categories. Since all medical devices (except things like, you know, tongue depressors) already require unique serial numbers, and furthermore all medical device vendors are required to maintain a device history file for each medical device. The FDA would also have the authority to waive the labeling requirement for some manufacturers. "One of the complications the FDA will have to face is that medical devices include everything from Band-Aids to very complicated implantable devices," said Joe Pleasant, chairman of the Coalition for Healthcare eStandards--an advocacy organization that has worked with the FDA on the issue. "I think what the agency may try to do is say requirements will be different depending on the class of the device." The potential benefits from this are all dependent on the creation of an industry wide numbering scheme ($$), electronic systems for vendors to track products and issue/manage recalls ($$$), and similar systems for each medical device user so that device usage can be tracked and reconciled with vendor data ($$$$$).

Congress Passes Compromise FDA Bill Reauthorizing MDUFMA

September 25, 2007

The House and Senate last week passed a compromise bill reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA), as well as a similar program for prescription drugs. The Senate passed the bill, H.R. 3580, Sept. 20 without amendment through unanimous consent procedure, which does not require a roll call vote. H.R. 3580, the FDA Amendments Act, passed the House Sept. 19 by a vote of 405-7. The bill contains provisions from both H.R. 2900 and S. 1082, the FDA Revitalization Act. Since the House passed H.R. 2900 in July, House Energy and Commerce Committee staff has been meeting with Senate Health, Education, Committee and Pensions staff to reconcile the differences between the bills, Rep. John Dingell (D-Mich.) said. Without the bill, the program would expire Sept. 30, and FDA Commissioner Andrew von Eschenbach recently informed FDA staff that if the bill did not pass before Sept. 21, he would have to issue reduction-in-force notices to nearly 2,000 employees.

India to Introduce Medical Devices Regulation Bill

September 25, 2007

The Department of Science & Technology, Government of India has proposed to bring in a new legislation to enforce uniform and effective standards of Medical Devices throughout the country. This will ensure that substandard devices are not exported, especially to developing countries, which do not have medical devices regulation in place.

Device Makers Take a Chance on TV Advertising

September 25, 2007

As drug companies’ TV spots get splashier, makers of implants that treat the same symptoms are trying to overcome obstacles to competing on the airwaves.

Hospital Infection Rates More Than Halved by I-Flow Device

September 21, 2007

An I-Flow catheter is responsible for reducing surgical site infection rates by more than 50 percent and significantly shortening hospital stays when compared with traditional narcotic pain care, according to a recent study. The study, presented at the 47th Annual Interscience Conference on Antimicrobial Agents & Chemotherapy, showed that the company’s ON-Q PainBuster with ON-Q SilverSoaker Antimicrobial Catheter may save hospitals billions of dollars if used for post-surgical pain relief across multiple surgeries, I-Flow said. ON-Q is the only pain relief pump to include an antimicrobial catheter and the first and only one to document an infection reduction capability, it added. Results showed that the ON-Q patients were 55 percent less likely to develop a surgical site infection when compared with the control group, the company said. The patient’s average length of stay dropped to 6.1 days for ON-Q patients from 8.4 days for the control group, a 27 percent reduction.

House Passes Patent Reform Bill, Concerns Remain Within Industry

September 20, 2007

The House voted 220-175 this month to pass a patent reform bill, despite opposition from the White House and industry. The Patent Reform Act, H.R. 1908, and its Senate counterpart, S. 1145, weaken important protections by making patents easier to challenge and cheaper to infringe, according to AdvaMed general counsel Christopher White. White added that the bill is threatening patents at a time when American device makers need stronger protections to compete internationally. The House acted on H.R. 1908 Sept. 7, despite a letter from House Republican leadership to Speaker Nancy Pelosi (D-Calif.) asking her to continue to work on the bill instead of scheduling it for quick consideration. The Senate and House judiciary committees passed the Patent Reform Act, S. 1145 and H.R. 1908, in July. The act would convert the U.S. patent system from a first-to-invent system to a first-to-file system, which will give the system more clarity and certainty, according to Rep. Howard Berman (D-Calif.), who introduced the bill. The Bush administration does not support a provision in the bill that would limit a court’s discretion in determining damages to compensate for a patent infringement, according to a statement from the White House Office of Management and Budget. While the administration supports passing patent modernization legislation, it will oppose H.R. 1908 until that provision is revised, the office said. A copy of the bill is available at thomas.loc.gov/cgi

Canada Seeks to Improve Investigational Device Regulations

September 17, 2007

Health Canada has released a discussion paper seeking stakeholder input on proposed options for strengthening the regulation of medical devices undergoing clinical testing. In comparison with the FDA, the European Union and Australia’s Therapeutic Goods Administration, Health Canada is the only regulatory body that does not require conformance to good clinical practices (GCPs), imposes no monitoring requirements for interim and final reporting and conducts no inspections of clinical trial sites involving devices, the discussion paper says. The agency outlines several options for improving investigational device regulation, including maintaining the status quo. The option favored by Health Canada harmonizes Canada’s requirements with those of other international regulators, which could increase the number of clinical trials conducted in Canada and enhance the acceptance of Canadian products on the international market, the discussion paper says. The discussion paper “Investigational Testing of Medical Devices” can be accessed at www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/pcitmd_cpreeim_e.pdf.

Senate Bill Would Mandate Manufacturer/Physician Gift Disclosures

September 17, 2007

Sens. Herb Kohl (D-Wis.) and Chuck Grassley (R-Iowa) have introduced legislation to require medical device, drug and biologics manufacturers to disclose the amount of money and other gifts they give to physicians. According to the senators, S. 2029, the Physician Payments Sunshine Act, introduced Sept. 6, builds on similar state initiatives in Minnesota, Vermont, Maine and West Virginia. It would apply to manufacturers with $100 million or more in annual gross revenues, with penalties for not reporting physician payments ranging from $10,000 to $100,000 per violation. In addition, S. 2029 would require the HHS secretary to create a website and post payment information in a clear and understandable manner.

White Paper Details Sterility Testing Essentials for Medical Device Manufacturers

September 12, 2007

In the white paper titled “Sterility Testing: Essential Things You Must Know,” author Steven Richter, Ph.D., president and scientific founder of Microtest, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies. Sterility testing of medical devices is required during the sterilization validation process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time to market. Microtest is a leading provider of medical device services and analytical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology in the delivery of medical device sterilization validations, package validations, microbiology and clean room services.

Lawyers Predict Increased Marketing Scrutiny for Device Makers

September 1, 2007

Devicemakers should be on the lookout for increased FDA enforcement of promotion regulations, according to attorneys from Arent Fox. Some of the biggest healthcare fraud prosecutors in the field have been speaking publicly about impending device investigations, Linda Baumann said at an FDAnews audioconference. Since November 2006, there have been numerous warnings from prosecutors about device investigations, including off-label issues, she said, adding that approximately half of all uses of drug-eluting stents in 2004 and 2005 were off-label. “It’s only a matter of time before the medical device industry sees almost the same amount of scrutiny in the context of enforcement as we’re seeing now in pharmaceuticals,” James Ravitz added.

Firms Should Track Unusual Sources of Device Complaints

August 31, 2007

The fastest way for medical device firms to get a warning letter is not to report adverse events to the FDA, according to Judith Andrews, director of quality and compliance services for Medical Device Consultants. One major pitfall for companies is failure to recognize all sources of complaints, she said, speaking at an FDAnews audio conference. Often the FDA taps data sources that may not be obvious to the manufacturer, Andrews said. Firms must establish methods to identify complaints from a variety of sources, she said. For example, they should check the MedWatch voluntary reporting program, as well as journal articles and meetings. “This has become an even more critical objective in the recent past,” Andrews said. She added that there have been “severe repercussions” from device complaints brought up at academic meetings, requiring major investigations by medical device companies.

Health Canada Outlines 2007-2012 Strategic Plan for Medical Devices

August 16, 2007

Health Canada has announced a five-year plan for the Medical Devices Program (MDP) that includes new measures to increase risk management of clinical trials and postmarket activities, punish firms that fail to comply with MDP regulations, and stem the distribution and sale of counterfeit devices. The MDP currently oversees approximately 1,600 licensed medical device establishments and more than 60,000 licensed medical devices, the agency said. With the number of products “continuing to grow exponentially, it is increasingly challenging to maintain the level of service Canadians and industry require within the current budget,” the plan says. The plan also addresses human resource and finance issues. According to Health Canada, the MDP had approximately 150 full-time employees and a budget of more than $11 million in fiscal 2005-2006.

Lawmakers Say They Will Work on MDUFMA During Recess

August 15, 2007

Four top lawmakers sent a letter to FDA Commissioner Andrew von Eschenbach saying they would continue work on legislation reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA) over the August recess. The legislation reauthorizes MDUFMA and other public health programs for five years and allows the FDA to charge user fees for the review of medical devices. The current user fee program expires Sept. 30. The bills, H.R. 2900 and S. 1082, are currently pending before a conference committee. Sen. Edward Kennedy (D-Mass.), Senate Majority Leader Harry Reid (D-Nev.), House Speaker Nancy Pelosi (D-Calif.) and Rep. John Dingell (D-Mich.) told von Eschenbach that work on a conference report would continue throughout August despite the congressional recess. More information on S. 1082 can be seen at thomas.loc.gov/cgi-bin/bdquery/z?d110:s.01082:. More information on H.R. 2900 can be seen at thomas.loc.gov/cgi-bin/bdquery/z?d110:HR02900:.

Global Task Force Issues Guidance on Device Clinical Trials

August 14, 2007

Two new guidance documents from the Global Harmonization Task Force (GHTF) address basic concepts of clinical evidence and procedures for conducting and documenting clinical evaluations involving medical devices. The final documents — “Clinical Evidence — Key Definitions and Concepts” and “Clinical Evaluation” — are the first issued by Study Group 5, which was established in 2002 to promote harmonization of clinical safety and efficacy requirements for medical devices. The guidance defines clinical evaluation as an ongoing process carried out over the life cycle of a medical device. Following the assessment of clinical data leading to the marketing of the device, the manufacturer should establish postmarket surveillance programs to monitor the ongoing clinical safety and performance of the device, tailoring the scope and nature of the surveillance to fit the device and its intended use, the guidance says. These periodic reassessments will permit firms “to communicate with conformity assessment bodies and regulatory authorities, in accordance with local reporting requirements, any information that has an important bearing on the benefit-risk assessment of the device or that would indicate a need for labeling changes regarding contraindications, warnings, precautions or instructions for use, etc.,” the guidance explains. The documents can be viewed at www.ghtf.org/sg5/inventorysg5/sg5_n1r8_2007final.pdf The documents can be viewed at www.ghtf.org/sg5/inventorysg5/sg5_n2r8_2007final.pdf.

Guidance Addresses Medical Device Exports

August 14, 2007

The FDA announced the availability of a guidance addressing medical device exportation under the FDA Export Reform and Enhancement Act. The guidance document provides information on the statutory and regulatory requirements for exporting FDA-regulated products. It replaces a previous draft guidance to help industry understand and comply with the act, which “significantly changed” the export requirements for devices and drugs, the FDA said. The guidance, “Exports Under the FDA Export Reform and Enhancement Act of 1996,” can be found at www.fda.gov/OHRMS/DOCKETS/98fr/98d-0307-gdl0002.pdf. Device Off-Label Promotion: Case Studies to Prepare for Increased Enforcement An FDAnews audioconference Tuesday, Aug. 28, 2007 • 1:30 p.m. — 3:00 p.m. EDT Attorneys James Ravitz and Linda Baumann will examine the current and up-coming off-label promotion environment in this 90-minute audioconference. They'll describe how government prosecutors consider device companies differently than pharmaceutical corporations, and how that impacts their enforcement activities. They'll also provide strategies specific to device companies, based on recent case studies, to ensure compliant promotional activity. Register online or call toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

NSAI Offers European and Canadian Certifications Within 60 to 90 Days

August 13, 2007

A U.S. subsidiary of the notifying body National Standards Authority of Ireland (NSAI) is refocusing its certification efforts by offering device manufacturers a way to obtain European Union (EU) approval or Canadian Medical Devices Conformity Assessment System (CMDCAS) certification within 60 to 90 days, Chris Morrell, vice president of NSAI’s U.S. division, said. Morrell explained that it often takes device manufacturers 90 to 120 days just to get on a schedule for certification, and it could take months to years for a firm to obtain a CE mark, necessary for marketing a device in the EU, or CMDCAS certifications. NSAI’s new certification process for medical devices applies to CE marks, CMDCAS certifications and global ISO 13485 certifications, Morrell said.

House Approves Act to Compare Devices

August 9, 2007

The House voted 225-204 Aug. 1 to pass H.R. 3162, the Children’s Health and Medicare Protection Act of 2007. The Senate version of the bill, S. 1224, passed by a vote of 68-31 Aug. 2. The House bill includes “significant funding” — $375 million by 2011 — for comparing the effectiveness of medical devices and prescription drugs, and making those results publicly available, according to Consumers Union. But the legislation still faces some challenges. According to Rep. John Dingell (D-Mich.), “President Bush has pledged to veto counterpart legislation in the Senate.” More information on H.R. 3162 can be found at thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.03162:. More information on S. 1224 can be found at thomas.loc.gov/cgi-bin/bdquery/z?d110:s.01224:.

Manufacturers Should Submit Data Now for Emergency Use Authorizations

August 6, 2007

Emergency use authorizations (EUAs) for unapproved medical products or unapproved uses for them may not be issued until after the HHS secretary has declared a public emergency. However, the FDA “strongly encourages” companies with EUA product candidates to submit data before the determination of an emergency, according to a new guidance. The guidance, issued last week, explains the FDA’s policies for authorizing the emergency use of unapproved products or unapproved uses of approved medical products during certain public emergencies, such as a heightened risk of attack on the public. The range of potential EUA products includes medical devices, drugs and biologic products. The guidance, “Emergency Use Authorization of Medical Products,” can be seen at: www.fda.gov/oc/guidance/emergencyuse.html

Rules Evolving on Reporting Device Trial Adverse Effects

August 6, 2007

Reporting of unanticipated adverse device effects (UADEs) in clinical trials of devices is subject to a different set of rules than adverse event reporting in drug trials. Although the two areas are related, devices have not received as much attention as drugs, Mark Barnes, chief operating officer of St. Jude Children’s Research Hospital, said in a recent FDAnews audio conference. Due to increasing litigation, reporting of patterns of events is becoming more important, Barnes added. If a research subject is injured, his or her attorney can point to an alleged failure to report such a pattern. One unfortunate side effect of these trends has been over reporting of both adverse events and UADEs by sponsors. Institutional review boards are flooded with adverse event reports — some are receiving more than 10,000 reports annually. The danger is that quantity will drown quality: “A surfeit of reports is not as good as analysis,” Barnes said. In an effort to dam up this flood of unhelpful paperwork, the FDA issued a guidance on reporting adverse events, including UADEs, and which events do not have to be reported.

FDA Issues Guidance on 510(k)s for Pulse Oximeters

August 2, 2007

In a new guidance document, the FDA discusses its recommendations for premarket notification submissions, or 510(k)s, for pulse oximeters, which use radiation to measure blood oxygen saturation. For this type of device, the agency recommends using an abbreviated 510(k), a submission that includes a coversheet, proposed labeling and a summary report. The summary report should briefly describe the methods or tests used and a summary of the test data or description of the acceptance criteria used to address the risks identified in the document. Submissions should also identify any additional risks specific to the particular device. The guidance, “Pulse Oximeters — Premarket Notification Submissions [510(k)s],” can be viewed at: www.fda.gov/cdrh/ode/guidance/1605.pdf.

EC Releases Revised Guidance on Medical Device Vigilance

July 11, 2007

The European Union’s latest guidelines on medical device vigilance call for quicker turnaround on reporting adverse events after incidents have occurred. “Medical Devices Vigilance Guidance System MEDDEV version 5,” released last month by the European Commission (EC), sets a two-day time frame for reporting incidents involving a serious public health threat. In the event of a death or unanticipated serious deterioration in a patient’s state of health, manufacturers should submit a report to the competent authority “immediately” upon determining a link between the device and the event. This should be no later than 10 days following the incident, the guidance says. All other incidents should be reported no later than 30 days after the company becomes aware of the incident. If the manufacturer is unsure whether an event is reportable, the firm must still file a report within the time frame for that type of incident, the guidance says.

EC, U.S. to Exchange Confidential Device Safety Information

July 9, 2007

The European Union (EU) Delegation of the European Commission (EC) to the U.S. said July 5 that the EC and the FDA agreed to confidentiality arrangements that will allow the two to exchange confidential information about the safety of medical devices. “We agreed to put in place a new framework for transatlantic economic integration,” said EC Vice-President Günter Verheugen, European chairman of the Transatlantic Economic Council and commissioner for Enterprise and Industry policy. The types of information covered in new confidentiality arrangements include: Advance drafts of legislation and/or regulatory guidance documents; Post-marketing data and information that could have an impact on the public health, such as vigilance data or information about impending regulatory actions; and Information on ongoing and emerging regulatory issues of health and safety in the U.S. or the EU.

China’s Medical Device Industry Profit Growth Rises 33 Percent in Jan. to May Period

July 9, 2007

China’s medical device industry recorded profits of RMB 1.59 billion ($209.75 million) from January to May of this year, representing a growth rate of 32.96 percent over the same period last year, according to the latest government statistics.

Medical Device Manufacturers in West Michigan Join Forces to Promote Their Expertise

July 3, 2007

Medical device manufacturers in West Michigan have initiated a consortium to promote their specialized expertise in medical device products, from design through manufacturing, to companies worldwide.

Proposed Patent Reforms Worry Device Industry

June 25, 2007

Industry groups say the Patent Reform Act of 2007 threatens to “devastate life sciences investment” by weakening the patent system for medical device makers. Provisions regarding apportionment of damages in lawsuits, rulemaking authority for the Patent and Trademark Office and post-grant patent oppositions will “create a chilling effect on the industry,” according to the Medical Device Manufacturers Association. The legislation passed the House Subcommittee on Courts, the Internet and Intellectual Property last month and is now pending markup by the full House Judiciary Committee. The Senate Judiciary Committee held a markup on its version of the legislation June 21. Under the apportionment provision, damages for patent infringement would never be more than the economic value attributable to the innovation, AdvaMed said. In the medical field, many “critically important” advances are incremental and build upon prior technology. By apportioning damages to the economic value attributable to the specific contributions over the prior art, the act would severely diminish the value of medical device patents, AdvaMed added. MDMA agreed, saying, “Even if the patented invention is truly the reason for the sale of an entire product, but … is virtually costless to add to the product, the patentee would obtain virtually no royalty.”

New European Medical Device Directives Expected This Fall

June 18, 2007

The new European medical device directives are expected to be adopted this fall, implemented by the end of 2008 and enforced by 2010, Cristiana Spontoni, European partner with Squire, Sanders & Dempsey, said at the recent FDAnews Medical Device Quality Congress. The European Parliament recently approved the amendments to the directives. The amendments narrow the definition of a single-use device and obligate the European Commission to further study the practice of reprocessing single-use devices, according to Spontoni. Although industry generally supports the new rules, Spontoni noted, “The devil is in the details,” and recommended manufacturers pay attention as the rules are adopted and implemented. During the conference, Spontoni discussed some of the key changes under the amendments, including new requirements for notifying bodies. Under the European system, notifying bodies are designated by member state regulators and evaluate a product’s compliance with requirements for CE marking. All medical devices in Europe must have a CE mark to be commercialized.

FDA Aggressively Enforcing cGMP Violations

June 15, 2007

Over the last 18 months, the pendulum has swung back to aggressive FDA enforcement of current good manufacturing practices (cGMPs) for medical devices, Mark Brown, a partner with King & Spalding, said at the FDAnews Fourth Annual Medical Device Quality Congress. “FDA hates being called on the carpet at congressional hearings and accused of allowing a product either [to enter] the market [if it has] had problems, or allowing a product to remain on the market if there are known safety issues associated with it,” Brown said. “It’s a very big problem, and you’re going to see it manifest itself in ways that you probably haven’t seen before.” If the FDA has concerns with a manufacturer’s cGMP compliance status and asks the firm what its intentions are for the relevant product, Brown said the agency is likely to consider removing the device from the market.

FDA Accepting Comments on Electronic Collection of Adverse Event Forms

June 15, 2007

The FDA is announcing a public comment period on the continuation of a pilot project evaluating the electronic collection of the 3500A form for device adverse events. The project is intended to obtain data from user facilities, such as hospitals, participating in the Medical Product Safety Network (MedSun). Additionally, the electronic form will include hospital profile information and several other questions related to the use of medical products. A portion of the MedSun software, called Device Safety Exchange, is a moderated site where MedSun members may share information with each other. Written comments must be submitted by Aug. 13.

FDA Wants Third-Party Review Program Renewed

June 14, 2007

Third-party reviews for premarket notifications, or 510(k)s, are a “useful alternative” for device manufacturers and are likely to become even more beneficial, the FDA said in a report provided to Congress last month. The agency recommended renewal of the program as part of reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA). The agency gave the report, “Third Party Review of Medical Device Premarket Notifications,” to the House Energy and Commerce Committee to aid the committee in its consideration of the user fee bill. The report, which was originally due Jan. 10, was again requested by Rep. Frank Pallone (D-N.J.) at a recent hearing on medical device user fees. Currently, the FDA can allow accredited third-party reviewers to conduct primary reviews of premarket notifications for certain low- and moderate-risk devices. This authority will sunset Oct. 1 unless it is renewed as part of MDUFMA reauthorization. A 510(k) reviewed by a third party reaches a final determination more rapidly, on average, than a comparable 510(k) reviewed entirely by the FDA — although the difference has declined over time, the report said. In fiscal 2005 the difference in the average review times was 13 days, compared with 45 days in fiscal 2000.

FDA Reclassifies Body Fusion Devices

June 12, 2007

The FDA is reclassifying intervertebral body fusion devices that contain bone-grafting material from Class III (premarket approval) into Class II (special controls), the agency announced in the June 12 issue of the Federal Register. Devices that contain any therapeutic biologic (e.g., bone morphogenic protein) will remain in Class III. This reclassification, effective July 12, is based on the recommendation of the agency’s Orthopaedic and Rehabilitation Devices Panel. The Federal Register notice can be viewed at: www.fda.gov/OHRMS/DOCKETS/98fr/E7-11240.htm

FDA: MDUFMA Funds, ‘Additional Effort’ Needed for Postmarket Surveillance

June 11, 2007

The FDA has identified several areas where “additional effort” is needed to ensure effective postmarket surveillance of medical devices. The agency discusses these areas, and the effect of user fees on postmarket surveillance, in a report it provided to Congress. The agency gave the report, “Effects of the Medical Device User Fee Program on Postmarket Surveillance of Medical Devices,” to the House Energy and Commerce Committee after Rep. Frank Pallone (D-N.J.) requested it last month at a hearing on medical device user fees. The report was originally due Jan. 10. According to the report, reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) is essential to sustaining and improving postmarket surveillance of medical devices. Without the funding provided under this bill, the FDA would be forced to “substantially reduce” its medical device program, resulting in a “serious degradation” of its ability to conduct postmarket surveillance.

FDA Cites Sponsor of Combination Product Trial

June 7, 2007

The sponsor of a clinical trial studying a combination product received an FDA warning letter for giving the clinical investigator and institutional review board a misleading risk assessment and not providing the FDA information and access to its premises. The warning letter, sent April 26 and posted recently on the FDA website, deals with a clinical trial of CPC of America’s vascular closure system MedClose. The agency said the company provided misleading information that made it impossible to conduct an appropriate review of the study. According to the warning letter, CPC’s risk assessment stated that MedClose and the fibrin plug to be used with it “do not present a potential for serious risk to health, safety or welfare of a subject.” However, the labeling for the approved use of the Tisseel VH Fibrin Sealant identifies a number of risks, some life-threatening, which would be expected to be present when it is used with MedClose, the warning letter said. CPC did not disclose these risks in the informed consent form it provided to the clinical investigator, the letter added. Further, while Tisseel is approved for other uses, it is not a licensed biologic for use with MedClose, the letter stated.

Trial Monitors Must Know Different Regulations for Devices

June 4, 2007

While many of the principles and regulations governing clinical trials of medical devices are similar to those for drugs, there are some significant differences that study monitors should be aware of, according to Lee Truax-Bellows, president and CEO of Norwich Clinical Research Associates. One example is that documentation of device accountability is required for an investigational device approved for an indication other than that which is the subject of the trial, Truax-Bellows said during a recent FDA news audio conference. In such a case, the device “must be labeled investigational” to distinguish it from the approved use of the same device. Also, mandatory disclosure of potential conflicts of interest can be “trickier in the device world, because the [device] inventor is often a healthcare professional,” she said. For example, if the inventor owns a lot of stock in the company bringing the product to market, this must be disclosed to the FDA. Another consideration unique to device trials is that durable devices can be sold to the site, “but not for more than the R&D expense.” Otherwise, there is a danger that acquiring a costly device could become an inappropriate financial incentive for the site, Truax-Bellows said. Moreover, the site must agree to stop using the device if it ultimately does not receive approval.

EU Health Council Adopts Medical Device Directives

June 4, 2007

The European Union (EU) Health Council has accepted the compromise package on the medical device directives adopted March 29 by the European Parliament, Eucomed announced. This package will “strengthen the competitiveness of European industry,” Eucomed said. It added that guidance documents and secondary legislation must be developed to ensure the new provisions are adequately implemented. Work is also “urgently required” to evaluate the impact on patient safety of reprocessed single-use products.

Industry Fears ‘Unintended Consequences’ of Pediatric Device Legislation

May 28, 2007

Industry is worried that pending pediatric medical device legislation may have unintended consequences, including disincentives for creating or testing devices for use in children. At a House Subcommittee on Health hearing this month, the Medical Device Manufacturers Association (MDMA) voiced concerns about provisions increasing FDA authority for postmarket surveillance of pediatric devices. However, it supported proposed changes to the humanitarian device exemption program. The Senate voted 93-1 May 9 to pass S. 1082, the “FDA Revitalization Act,” which contains legislation addressing pediatric medical device development. A bill pending in the House, H.R. 1494, the “Pediatric Medical Device Safety and Improvement Act,” contains the same provisions for pediatric medical devices as S. 1082. S. 1082 and H.R. 1494 would permit the FDA to order a postmarket surveillance study for a Class II or Class III device “that is expected to have significant use in pediatric populations.” MDMA said it feels this is “unnecessary” because the agency currently has “ample authority” to order postmarket surveillance for certain Class II or Class III products, such as devices reasonably likely to have serious adverse health consequences.

European Parliament Approves Medical Device Directives

May 21, 2007

Paving the way for improvements in medical device regulation in the European Union, the European Parliament adopted more than 100 amendments to medical device directives. Among the 141 amendments approved were clarifications on the use of software in medical products, stricter labeling requirements for devices that potentially leach phthalates into the patient’s body and pressures on device makers to replace high-risk materials with alternative substances and to avoid the use of substances that cause cancer, mutations or reproductive toxicity. The amendments package, which revises the European Commission’s original 2005 proposal, is expected to be adopted quickly.

Investigations Focus on Illegal Marketing by Medical Device and Supply Companies

May 18, 2007

Government law enforcement agencies have made it known that illegal marketing and promotional practices of medical device and supply companies are now the targets of investigations basically because lawmakers who oversee spending by public health care programs say the booming business in this field of medicine is a little too good to be true.

Device Trial Sponsors Cited in Two Warning Letters

April 23, 2007

A hearing implant company sponsoring a device study failed to provide clinical investigators with information on hearing loss among participants, and the sponsor of another device clinical trial provided "misleading" assurance to participants that the investigational device had been judged safe by the FDA, according to two separate FDA warning letters posted recently to the agency's website. Although Cochlear Americas stated that investigators in its clinical trial received hearing loss information in an annual progress report submitted Sept. 24, 2004, "according to exhibits collected during the inspection, the hearing loss was not documented until 2005," the FDA warning letter, sent to company President Chris Smith March 13, said. Another sponsor, called KSM, included in its informed consent document the "misleading statement" that the device "has been pronounced safe by the FDA, being in their terminology a non-significant risk," although it "is an investigational device [and] therefore, the FDA has not determined its safety and effectiveness," the agency said in a March 14 warning letter. Neither Cochlear Americas nor KSM responded to requests for comment by press time. The Cochlear Americas warning letter can be accessed at: www.fda.gov/foi/warning_letters/b6292d.htm and the KSM warning letter can be accessed at: www.fda.gov/foi/warning_letters/b6294d.htm

Confidentiality in Clinical Trials: Understand Your Liability

April 13, 2007

This management report from FDAnews, shows you how to develop a plan to protect yourself from liability and educate your investigators and staff about the importance of upholding confidentiality agreements. Confidentiality in Clinical Trials: Understand Your Liability is a first-line resource to help you learn what the issues are and what you need to do to keep your data secure and your organization safe from unwanted intrusion.

MHRA Updates Guidance on Reporting Adverse Events

April 9, 2007

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a bulletin providing new guidance on reporting and disseminating information about adverse incidents involving medical devices. The guidance, "Reporting Adverse Incidents and Disseminating Medical Device Alerts," replaces a January 2006 document. It provides information on what is a medical device, what constitutes an adverse event and when to report it, how to report incidents, what to do with devices involved in incidents and how the MHRA responds to and manages reports. It also addresses the dissemination of medical device alerts and field safety notices and corrective actions. According to the guidance, the MHRA received reports of approximately 8,000 adverse incidents in 2006. Of those, roughly 26 percent required standard investigations and 27 percent necessitated in-depth investigations. The rest were reported as part of the agency's ongoing trend analyses.

Confidentiality in Clinical Trials: Understand Your Liability

April 4, 2007

This management report from FDAnews, shows you how to develop a plan to protect yourself from liability and educate your investigators and staff about the importance of upholding confidentiality agreements. Confidentiality in Clinical Trials: Understand Your Liability is a first-line resource to help you learn what the issues are and what you need to do to keep your data secure and your organization safe from unwanted intrusion.

How to Coordinate Clinical Investigators and Institutional Review Boards to Ensure GCP Compliance

March 30, 2007

This management report, is packed full of actionable, expert guidance to help you build a quality assurance program using a proven framework, identify and remedy common clinical study weaknesses, avoid regulatory action and streamline the clinical processes. This report also delivers 5 case studies that examine the top site and Institutional Review Board Compliance issues.

FDA Releases Draft Guidance on Device Modifications

March 19, 2007

New draft guidance advises manufacturers of Class III devices subject to premarket approval (PMA) requirements on when to use certain PMA supplements. Firms must submit PMA supplements prior to making changes that alter the safety or effectiveness of their devices, the guidance says — unless certain exceptions apply. Modifications requiring a supplement include changes to a device's indications, labeling, sterilization procedures, expiration date or packaging. The agency provides guidance for determining the type of PMA application (e.g., original, panel-track supplement, 180-day supplement, real-time supplement and/or special PMA supplement) required if a company modifies the design or labeling, manufacturing process, manufacturing location or packaging of a device. The guidance also gives examples of modifications, descriptions of the testing to support these changes and the types of PMA applications that were submitted for them. The document, "Draft Guidance for Industry and FDA Staff — Modifications to Devices Subject to Premarket Approval (PMA) — The PMA Supplement Decision-Making Process," replaces the draft titled "Modifications To Devices Subject to Premarket Approval — The PMA Supplement Decision Making Process" and can be viewed at www.fda.gov/cdrh/ode/guidance/1584.html.

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