Weekly Device Summaries for May 24 - 28, 2010

FDA Proposes Publicizing Device Information Before Marketing Approval.  On May 19, 2010, FDA requested public comment on a series of 21 proposed policy changes at the agency, which seek to increase the availability of information on FDA regulated devices.  The proposals include publicizing certain information that was previously not made public prior to marketing approval, such as whether a company has requested permission to conduct a clinical trial, or whether a company has submitted a 510(k) or premarket approval application for a device.  FDA also proposes publishing data summaries, as well as the draft indications for use of a device, from marketing applications under review by the agency.  FDA also suggests publicizing agency decisions to not approve a device for marketing.  Comments on the proposals are due July 20, 2010.

Increase in Device Recalls Concerns FDA.  Class I recalls of medical devices have increased significantly in recent years, FDA officials said at a recent conference.  In the past seven months, the agency has seen almost 30 Class I recalls, nearly the same number as the entire previous year.  Typically, FDA designates only the most serious device recalls as Class I, as the category is intended for cases in which use of the defective device could cause a reasonable probability of serious injury or death.  FDA officials are concerned about the increase in recalls, and is wondering whether device companies are rushing products to market at the expense of quality. 

Device Complexity May Play Role in Radiation Therapy Errors.  Experts participating in a recent webinar claim that accidental over- or under-exposure to radiation can be partially attributed to the increasing complexity of new technologies.  According to the participants, while technologies such as stereotactic radiosurgery and image-guided radiation therapy allow for more precise radiation delivery, the additional steps required to operate these technologies can introduce error.  To prevent these errors, the experts suggested limiting use of specialized technologies to certain treatment centers or improving the process whereby device makers train hospitals when a new device is installed.

Industry Expresses Anxiety at 510(k) Forum.  At a recent town hall meeting, the medical device industry discussed its concerns over planned reform of the FDA 510(k) premarket clearance program.  The forum drew more than 500 device companies, venture capitalists, patients, and even members of Congress, many of which expressed anxiety due to the current regulatory landscape.  The meeting was the first of three held by FDA to discuss the agency’s priorities, which include a potential overhaul of the 510(k) program.  Device firms are concerned about their ability to successfully navigate the FDA regulatory process and to obtain funding for development of new devices, given the uncertainty over the future of the 510(k) program. 

Weekly Device Summaries for May 17 - 21, 2010

FDA Creates Postmarket Surveillance Program for Devices.  FDA has recently launched a pilot program that would collect and analyze post-market data on medical device safety from five different hospitals.  The Massachusetts-based program is now operational and collecting data on a monthly basis, which is stored in a centralized database at Harvard Medical School.  The pilot program also is testing a data analysis system that would generate alerts about potentially unsafe devices, based on the data collected by the participating hospitals.  FDA hopes the pilot will provide insight into how the agency could incorporate device tracking into its post-market surveillance program for drugs, currently called the “mini-Sentinel” system. 

Report Urges Collaboration in Designing Medical Technologies.  Nurses and clinicians should be consulted further by device companies designing new medical technologies, according to a recent report by the Robert Wood Johnson Foundation.  The report highlights findings from meetings of more than 1,000 nurses, physicians, and pharmacists, at which participants discussed current technological needs in acute-care hospitals.  According to the report, clinical users feel many medical technologies are not user-friendly, do not meet the specified need, or require tweaking in clinical use.  Participants overwhelmingly supported further involvement of practicing clinicians in the design and development of new technologies, to improve their utility and safety. 

Agency Calls for New Diabetes Tests.  FDA is urging makers of diagnostic tests to focus on the development of new diabetes screening tests, to aid in identifying people at risk of the disease.  At a recent meeting, agency representatives noted that current diabetes tests are intended for screening people at high risk for the disease, resulting in a need for tests that could identify people at intermediate risk.  Additionally, FDA believes there is an increasing need for tests that could identify people at high risk for diabetes who are not typically tested because they are in low-risk populations.

Weekly Device Summaries for May 10 - 14, 2010

FDA Misses Targets for Premarket Review of Devices.  FDA missed some of its performance goals for premarket review of medical devices in 2008, according to Jeffrey Shuren, the director of FDA’s device center.  The FDA Amendments Act of 2007 set performance goals for the agency, such as reviewing 60% of all medical device premarket approval applications (“PMAs”) within 180 days of submission of the application.  Though the device center is on track to reach its goals for timely review of 510(k) submissions, the center did not meet its goal with respect to PMAs.  According to Shuren, an increase in the FDA’s workload, as well as the ambitious nature of the performance goals, contributed to FDA falling behind.  

FDA to Create Device Epidemiology Network.  FDA has announced a new public-private initiative that hopes to compile, synthesize, and improve epidemiological studies of medical devices.  The Medical Device Epidemiology Network would be a partnership between FDA, academia, and possibly industry, and seeks to help the agency assess device performance throughout the life cycle, based on various data sources.  The Network would compile data from studies, registries, and administrative databases, both foreign and domestic.  By compiling data for currently marketed devices, agency staff note that the initiative could potentially reduce FDA-mandated post-approval studies. 

FDA Weighs in on Non-inferiority Device Trials.  Speaking at an industry workshop, FDA staff noted that clinical trials attempting to show that a medical device is non-inferior to a control treatment present challenges for both study design and agency review.  Difficulties such as selecting a proper control and effectively blinding subjects and study investigators to treatment assignments render such non-inferiority trials challenging.  Moreover, the question of what is truly inferior—and therefore, how much the results can differ for the study device and the control treatment—can be difficult to assess.  Though FDA has not officially sanctioned its use, speakers at the workshop referenced FDA guidance for non-inferiority trials of drugs, which may aid companies designing non-inferiority studies of devices.