New DRAFT FDA Guidance Published Today – Nonbinding Feedback

Tommy McMaster |

Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding “non-binding feedback” after FDA inspections of certain medical device establishments.

Limited to statutory (FDARA 704) situations involving a “public health priority”, “implicat[ion] of systemic or major actions” or “relat[ing] to emerging safety issues (as determined by [FDA])”, this Guidance is nonetheless important, and presents, from my perspective, more risk than benefit for companies that rely too heavily on FDA’s feedback in these limited situations.

Responding to an FDA 483 is one of the most critical actions a company can take. Done well and sufficiently, the response can eliminate huge potential costs in the future. Done poorly and non-comprehensively, not understanding the Agency’s concerns — well — get ready to open your wallet. Comments are due on this guidance under docket number FDA-2018-D-4711, starting February 19, 2019 for 60 days. Thoughts are welcome.

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