In 2016, the Office of Compliance at the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health issued a total of 17 warning letters to medical device manufacturers citing violations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping.  The 2016 warning letters inform current trends in reporting enforcement.

All but one warning letter (16 letters) cited violations of 21 C.F.R. 803.17, which describe the requirements for developing, maintaining, and implementing written medical device reporting (MDR) procedures.  Of the 16 letters, 7 letters determined that the company did not have a written procedure or plans to implement a written procedure that would satisfy the requirements of section 803.17.  The remainder (9 letters) described deficiencies with the manufacturer’s current procedures for MDR reporting.

Common deficiencies included:

  • omitting important terms defined in 803.17, such as “cause or contributed,” “become aware,” “malfunction,” “MDR reportable event,” and “reasonably suggests.”
  • omitting a description of which sections of FDA Form 3500A will need to be completed to include all information found in the firm’s possession.
  • failing to address the circumstances under which a manufacturer would need to submit a 30-day, 5-day, supplemental or follow-up report and the requirements for each.
  • failing to describe how the firm will address documentation requirements.

Other violations cited in the warning letters include violations of sections 803.50(a)(1) (manufacturers failed to report that a device may have caused or contributed to a death or serious injury), 803.50(a)(2) (manufacturers failed to report that a device has malfunctioned and would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur),  and 803.53 (manufacturers did not identify and evaluate events occurring outside the United States as potentially reportable to FDA).

Given FDA’s focus on enforcing section 803.17, manufacturers may want to review their written procedures for MDR reporting and FDA’s recommendations included in the final guidance titled Medical Device Reporting for Manufacturers (Final Guidance), issued by FDA on November 8, 2016.  Our client alert discusses the Final Guidance’s key takeaways and the ways it differs from the 2013 draft guidance and the 1997 final guidance.

On February 16, Covington attorneys will present a webinar to provide more information about the Final Guidance, discuss current enforcement trends, and recommend steps that manufacturers can take to avoid common MDR reporting pitfalls.