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 The draft guidance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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