Device Corrections And Removals Guidance Undertaken By Industry, FDA

The National Electrical Manufacturers Association is developing guidance to help clarify reporting of corrections and removals of medical devices.

"Our hope is that this document, when it is finally completed to the satisfaction of FDA, will be incorporated into the inspectors' field manual," NEMA VP-Medical Products Bob Britain told participants at an AdvaMed meeting in Arlington, Virginia April 3.

NEMA was expected to meet with FDA regional operations representatives April 8 to discuss the latest version of the document.

At the AdvaMed meeting on device industry complaint handling, Britain sought to look beyond NEMA's constituency in drafting the document, inviting device reps to submit comments or examples that could be incorporated as part of the guidance.

FDA "has encouraged us to keep moving with this document" and to "enlarge the scope of the examples if we can," Britain said. There are "far more devices out there that we are not that knowledgeable of that could be included in this document."

Currently, the document includes definitions for corrections and removals-related terms as well as examples. "What we have attempted to do is look at the [corrections and removal] regulation [and] in our words clarify what is meant by 'correction,' 'removal,' 'routine servicing,' and 'risk to health,'" Britain explained.

In addition, "we go through and list lots of examples of events that should be reported" in a corrections and removals report, as well as "examples of events or happenings that should not be reported, in our opinion."

Although the April 8 meeting and revision of the current draft was imminent, Britain pointed out that there is still time for industry reps to get involved and collaborate in drafting the document.

"This will be a living document," he remarked, also noting that before the document reaches finalized form, "there will be a lot of back and forth between FDA and the trade associations."

FDA is currently working on a guidance to clarify 21 CFR 806, the regulation pertaining to corrections and removals, CDRH Recall Coordinator Maureen Bernier indicated. The corrections and removals regulation addresses when a manufacturer needs to report a recall-related action to FDA and also stipulates that manufacturers keep records of actions taken.

One point needing clarification is the definition of "removal," Bernier suggested. "We have a controversy inside the FDA as to what the definition of removal is."

Among other items that could be addressed in the FDA guidance are timeframes associated with reporting a correction or removal to FDA.

Firms have ten working days to report a correction or removal to the agency after initiation of an action. However, industry reps cited a lack of clear criteria for identifying what starts the ten-day clock.

"The definition is fluid," Bernier acknowledged. "A lot of people have defined that as the date when the letter is mailed."

Firms should not delay notifying FDA while they are drafting a corrections or removal letter, she recommended. "If we find an internal document that has a signature on it that says, 'Okay, at the end of this meeting, the action item was to prepare the letter and send it out,' bingo, there is your initiation."

Manufacturers submitting information via medical device report (MDR) in lieu of a corrections and removals report should include all the information that would go into the corrections and removals report, Bernier also recommended.

The CDRH official expressed interest in seeing the issue addressed through guidance. Information needs to be submitted by manufacturers because the underlying intent of the regulation is that "Congress wants the FDA to be involved and to know about health risks that are out there happening, in a timely manner," Bernier maintained.

The industry guidance being drafting under the aegis of NEMA eventually could be incorporated into the FDA guidance on 21 CFR 806, Britain speculated.