Medical devices, everything from tongue depressors to pace makers and defibrillators, are regulated by the FDA. How competently or effectively the FDA regulates these products has been questioned for several years in part due to the substantial increase in recent years in product recalls, for example the recall of certain hip implant devices. More specifically is the question whether the FDA's 510(k) process, that reviews or “clears for the market” medical devices, is adequate. An IOM study of the topic released in July 2011 reached the unanticipated and controversial conclusion that since, in part, 510(k) determines only “substantial equivalence” in clearing devices for the market, i.e., it does not evaluate device safety and effectiveness, the process should be scrapped and replaced. (Listeners will recall Dr. Zuckerman was interviewed last December about the excessive use of anti-pshychotics in nursing homes.)
During this 26-minute discussion, Dr. Diana Zuckerman defines what's meant by "substantial equivalence" and the three FDA classes of medical devices, she assesses what assurance the public has in knowing approved devices are safe, comments on her 2011 findings published in the Archives of Internal Medicine (see the link below) and the IOM report and what progress the FDA has made over the past two years in improving its medical device review process particularly in post-market surveillance.
Diana Zuckerman, Ph.D., has since 1999 been the President of the National Research Center for Women and Families, a nonprofit, nonpartisan research and advocacy organization promoting adult and child health and safety. After academic careers at Yale and Harvard, Dr. Zuckerman worked for many years as a Senate, House and Department of Health and Human Services staffer and as well serving as a senior policy advisor for First Lady Hillary Rodham Clinton and the White House Office of Science and Technology Policy. Presently, Dr. Zuckerman is also a fellow at the University of Pennsylvania Center for Bioethics and serves on the board of directors for two nonprofit organizations: the Congressionally mandated Reagan-Udall Foundation; and, the Alliance for a Stronger FDA.
Dr. Zuckerman's article noted above, "Medical Device Recalls and the FDA Approval Process," can be found at: http://archinte.jamanetwork.com/article.aspx?articleid=227466.