The Food and Drug Administration has adopted Guidance for industry and FDA staff regarding potential or planned medical device submissions. Issued on February 18, 2014, the Guidance supersedes a blue book memo dated March 25, 1999. Among other pre-market submissions, it concerns investigational device exemption (IDE) applications, premarket approval applications, humanitarian device exemption applications and 510(k) premarket notification submissions. The original feedback guidance applied to the pre-IDE program but FDA decided, by this new document, to broaden the scope of the program to a larger class of pre-submissions.
The Guidance is intended to create a structured process with clear recommendations, both for submitting parties and FDA. FDA has also committed in theory to timeframes for scheduling meetings and issuing meeting minutes – as well as committing to the advice provided in such meetings (assuming circumstances are not changed such that the advice is no longer applicable).
The Guidance is also intended to provide clear recommendations for applicants in preparing for and attending meetings with staff. It does not apply, however, to meeting requests from trade organizations or consumer or patient advocacy groups.
FDA strongly recommends making use of its online information resources prior to submitting a request for feedback.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
