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“No Surprise” That Medical Devices Are Under Scrutiny

Five weeks ago, I wrote a column entitled, “Re-Evaluating the Medical Device Approval Process.” It was not widely-read. I assumed it was because everyone already knew that a review was underway at FDA with more activity coming. Apparently, I was wrong.

A lot of people, including Wall Street, seemed surprised when FDA kicked its medical device re-evaluation effort into high gear over the last 10 days. I am not sure why they were surprised. The FDA re-evaluation was a certainty and has significant consequences for businesses and investors.

The medical device process and 510(k) approvals have been in question for a number of years. It has been a long time since there has been a thorough re-evaluation.  GAO is perpetually raising concerns about medical devices and a number of key Congressional leaders are interested. Also, the 510(k) approval process is necessary and defensible, but not easy to understand. It will continue to be a target for media, investigators, and crusaders until the process is re-evaluated and any needed changes made.

In April, Principle Deputy Commissioner Sharfstein acted affirmatively in response to the GAO’s early 2009 report on medical devices. Last week, FDA set out its plans for a credible, effective re-evaluation of medical devices. This latest phase of the re-evaluation process featured three major items from FDA:

  • Commissioning an IOM study of the medical device classification process, focused on the 510(k) process (which allows new devices to be approved by showing “substantial equivalence” to previously approved products);
  • Release of FDA’s analysis and recommendations based on review of the decision to grant 510(k) approval to a device manufactured by ReGen Biologics; and
  • Creation of internal working groups to recommend and implement changes without waiting for the IOM report.

As FDA made clear during its press conference, the ReGen case is not the reason for FDA’s review of the medical device approval process. Rather, approval of the ReGen device has proved to be instructive because so much went wrong. Among other things, there were violations of internal FDA protocols, inconsistent interpretations of the law, widespread confusion within FDA, poor communications with the sponsor company, and questionable involvement of Members of Congress

FDA has turned this experience into an inventory of ways to improve its performance in reviewing medical devices. FDA’s analysis of the ReGen approval is well-done and worth reading.

My earlier column had two purposes: to alert readers that medical device re-evaluation is a large, pending activity within FDA; and to argue for FDA to take strong steps so that the re-evaluation process would not be driven by Congressional hearings and legislation.

FDA has now taken those strong steps. I hope that Congress will respect this effort and not intervene.

If the medical device approval process is under re-evaluation….then scientific and medical review staff at FDA (and their supervisors) are going to be careful in their actions. Protocols will be followed, every step will be fully documented, all interested staff will be involved, and near-final decisions will be reviewed more carefully.

This will slow the FDA approval of medical devices until needed changes have been made and confidence in the process restored. Does this actually surprise anyone?


My original column is at: http://www.fdamatters.com/?p=448. This includes my explanation of the issues and why re-evaluation of the medical device approval process was certain to occur. I conclude that the end-result will be “more than a few tweaks and less than an overhaul” of the medical device approval process.

The FDA press release announcing the IOM study of the 510(k) process: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm

The ReGen report and the FDA news conference transcript: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm183745.htm

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