William Hyman: FDA Sets Deadlines for Itself–And Then Misses Them

July 9, 2013

Regulations

This past April, the U.S. Food and Drug Administration (FDA) issued an update to its plan to strengthen medical device postmarket surveillance. This update included 14 action items distributed among five broad categories. The action items have specific “deliverable dates” ranging from June 30, 2013 to Dec. 31, 2013. There were five items scheduled for June. Three of these pertained to the much discussed, much hyped, and long-awaited unique device identification (UDI) program. These three are:

  • Finalize the UDI rule.
  • Develop and implement a fully functional and publicly accessible global UDI database.
  • Complete an initial think-tank report to inform the development of a road map for successful UDI implementation.

At one point, the UDI final rule was scheduled for a May release, and then by the June deadline established by Food and Drug Administration Safety and Innovation Act (FDASIA) and cited in the surveillance plan. It has been reported that a final rule was submitted to the Office of Management and Budget in mid-June for their review. The third item is intended to be the crucial link between having UDIs, and actually putting them to good use.

The other two items with June 30 dates were:

  • Establish a Medical Device Registry Task Force.
  • Implement a mobile application for voluntary adverse event reporting.

Of these five, only the last point has been seen publicly. It was released in April on the same day as the surveillance plan itself. There has not yet been any comment on the value of the reports submitted via the app. The reports available online are overwhelming for drugs, and the search function is primitive.  For example entering “device” in the search box produces seven categories. Clicking on each of these seven results in the message of,  “No more product reports that match your filter criteria were found.” But in fact no such reports were found in any of the categories. Each report in the full list has one of three graphics associated with it. One is a pill and capsule, one is a syringe, and the third might be a valentine style heart with defibrillator paddles which presumably represents all devices. Almost all of the reports in the searchable database (all but one as of July 7, 2013) predate the app release and are presumably from its earlier incarnation. If you sign up and log in to the web version of MedWatcher, there is a different set of information available–which I will describe another time.

The next two rounds of postmarket surveillance deadlines are six items for Sept. 30, 2013, and three for Dec. 31, 2013.

The FDA is certainly hard pressed to accomplish all that it has been tasked with while operating under resource limitations (as are we all). Setting open deadlines for its initiatives is possibly better than no information or the proverbial “soon,” but not if these deadlines are not related to reality.  In this regard, setting June deadlines in April might have been interpreted as meaning that they were actually close to completing these items, and that they would therefore be likely to meet their own announced deadlines. This was apparently not the case, and now we must wait, as we always have waited, for the FDA to do what it has said it would do.

William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union. Hyman may be contacted at w-hyman@tamu.edu.

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One Comment on “William Hyman: FDA Sets Deadlines for Itself–And Then Misses Them”

  1. Anonymous Says:

    The FDA has posted the following update to its postmarket surveillance worklist at
    http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/default.htm

    “6/30/2013 UDI Expert Workshops”.

    Following this link brings you to one paragraph at the Brookings web site dated March 18, 2013 about a UDI Expert Workshop. Is this the report? If not, where is the report?

    Reply

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