FDA Issues Extensive Guidance Document Covering Medical Device Reporting Procedures

Posted 08 July 2013 | By Alexander Gaffney, RAC 

A new draft guidance document published by the US Food and Drug Administration (FDA) established an extensive repository of questions and answers related to reporting and recordkeeping requirements applicable to medical device manufacturers.

Chief among those requirements are those found under 21 CFR 803 - the medical device reporting (MDR) regulation - which mandates the submission of adverse event reports to FDA. The reports are intended to keep regulators informed of potential problems present or inherent in medical device products, and to prompt device manufacturers to (where possible) make changes to remove risks from devices.

The draft guidance is intended to explain the various requirements of the MDR in a question-and-answer format, acting as a sort of quick-reference for medical device manufacturers (but not, as the guidance notes, for facilities, importers or distributors).

Similar guidance documents were issued in 1988 and 1997, and FDA notes the current guidance supersedes both prior guidance documents.

Of particular interest to manufacturers may be FDA's identification of the 12 most common errors it sees in MDR reports. Those are, in order:

  1. Duplicate report sequence numbers provided in the Manufacturer Report Number box and Block G-9. Each report must have its own sequence number to avoid confusion.
  2. Multiple devices or events are included in the same report.
  3. The blocks in B-2 (Outcomes Attributed to Adverse Event) and B-5 (Description of Event or Problem) do not match or do not accurately represent the text contained in H-1 (Type of Reportable Event), H-10 (Additional Manufacturer Narrative), or H-11 (Corrected Data). If any information in Block B conflicts with the information in Block H, then you should provide an explanation in Block H-11 to address the conflict.
  4. Block D (Suspect Medical Device) is left blank or specific items within Block D are left blank.
  5. An importer submits a report on behalf of the manufacturer without requesting an exemption.
  6. The contact name and telephone number are not provided in Blocks G-1 and G-2, respectively.
  7. A 5-day report is submitted for an event that does not meet the 5-day report criteria.
  8. A report is marked as a "follow-up" report, but no follow-up sequence number is provided.
  9. No box is marked, or more than one box is marked, in Block H-1 (Type of Reportable Event).
  10. Codes required to be entered in Block H-6 (Evaluation Codes) are put in boxes on the wrong row. For example, an evaluation method code might be entered in the space for evaluation results codes or evaluation conclusion codes.
  11. Block H-7 information (If Remedial Action Initiated, Check Type) is not provided when the event relates to a remedial action.
  12. Event problem codes (patient problem codes and/or device problem codes) are not provided in Block F-10. 

The guidance is open for 90 days of public comment, after which time FDA will collect comments and likely issue final guidance shortly thereafter.

FDA: Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers

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