MASSDEVICE ON CALL — The FDA’s recent attempt to clear up confusion about official recall requirements got some negative reactions from members of the medical device industry, among them lobbying group AdvaMed and medical device company Boston Scientific (NYSE:BSX).

Both organizations submitted written responses to the FDA’s draft guidance, warning that the proposal hadn’t met its intention of clearing up the difference between a technology change that merits an official recall and one that counts as a "product enhancement."

Part of the problem has to do with the term "product enhancement" itself as well as other terms that the FDA hadn’t fully defined, Bloomberg BNA reported.

"We believe that distinguishing between ‘correction’ and ‘product enhancement’ and eliminating any overlap between them will help reinforce the understanding that modifications undertaken to correct violative products are recalls, whereas product modifications undertaken as part of a firm’s continuous improvement and sustaining engineering efforts are ‘product enhancements,’ and not a recall."

Boston Scientific at least lauded the federal watchdog agency’s efforts to improve its recall guidelines, but AdvaMed wasn’t so flattering, recommending that the FDA pull the draft altogether and issuing a new one at a later time.

"While this Draft Guidance addresses important policy issues, we believe significant aspects of the Draft Guidance are at odds with existing FDA regulation and policy, and that it is necessary to resolve these discrepancies prior to issuing guidance or regulation in this area," AdvaMed wrote.

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