ARTICLE
24 October 2014

FDA Alters Guidance On Reporting For Medical Device Recalls Versus Enhancement

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On November 5, 2014, the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions.
United States Food, Drugs, Healthcare, Life Sciences

In response to requests from manufacturers, FDA deleted a controversial section from the Guidance for Industry: Distinguishing Medical Device Recalls from Medical Device Enhancements, no longer requiring an 806 report for device enhancements. The draft guidance issued last year caused the medical device industry to voice its concerns about product liability suits and paperwork burdens if FDA required reporting of any enhancement intended to reduce health risks. The requirement as proposed would also have included reporting for unsold products the manufacturer upgrades as part of an enhancement. FDA removed several reporting requirements from the guidance, prompting a change in the title of the guidance, saying it revised the guidance document "to enhance clarity through the inclusion of multiple new examples." FDA also added a new sentence, clarifying that "changes to improve a nonviolative device's safety or performance" can fall in the category of product enhancements. On November 5, 2014, the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions.

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