William Hyman: The FDA’s Self-Imposed Deadlines (Part II)

Back in July, I wrote about the first deadline that the U.S. Food and Drug Administration had set for itself with respect to a series of activities to improve its postmarket surveillance system. Of the six items with a June 30th  deadline, I counted only one as completed. On the agency’s own scorecard, it counted two as completed by referencing some materials before the plan was even made public, which in my opinion don’t quite meet the goal, but why quibble? Of the four or five remaining from June, there has been progress only on the unique device identification system with the release of the UDI final rule on Sept. 20, followed by draft guidance on the global UDI database (GUDID) on Sept. 24. Presumably, the GUDID has to be completed before manufacturers can comply with populating it under the UDI rule.

Earlier, the Health IT Policy Committee of Office of the National Coordinator for Health Information Technology did incorporate UDI capability in its draft recommendations for Stage 3 of “meaningful use,” but without any details. An important issue for the healthcare technology management community relates to electronic health records (EHRs) and how UDI will be captured from the device or labeling. Barcode reading is the obvious choice, with typing in the long code a very poor alternative. (Barcodes have found multiple uses in the hospital environment, but often with different readers required, resulting in a proliferation of incompatible technologies.) Once the UDI is in one or more hospital databases, the next issue is how to put the codes to good use.

Sept. 30th marked the second target date in the FDA’s plan, this time for six more elements. Note that this was before the start of the 16-day government shutdown in October. These six are:

  • Establish a multi-stakeholder medical device postmarket surveillance system planning board.
  • Provide UDI requirements to the ONC for EHRs.
  • Implement prospective “data mining” tools.
  • Identify gaps in data standardization.
  • Advance the development of interoperability between registries and EHRs.
  • Collaborate on developing methodologies for evidence synthesis.

The last three of these are the sub-elements of “Develop and use new methods for evidence generation, synthesis and appraisal” as described in the aforementioned FDA scorecard. I have not seen publicly available information on any of these six, and none of them are noted on the FDA scorecard as having been completed. However, the scorecard also doesn’t show that UDI has been completed because the scorecard has not been updated since July 3rd.

So to date, the deadlines for 12 elements of the FDA’s plan have passed, with two to four completed, depending on who is counting.

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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