Draft guidance released by the FDA aims to clarify scenarios where changes to medical device design warrant a recall and help medtech firms differentiate those cases from product enhancements that do not constitute a recall. The guidance also outlines the regulatory standards for reporting a recall or product enhancement.
FDA guidance aims to clarify device enhancements, recalls
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Coats and Bennett PLLC
|Sr. Regulatory Specialist, Biotech Center of Expertise||
BASF, The Chemical Co.
|San Diego, CA|
Meridian Health Plan