FDA Finalizes Massive Rewrite of Device Pre-Submission Guidance

Posted 18 February 2014 | By Alexander Gaffney, RAC 

US Food and Drug Administration (FDA) officials on Tuesday released an extensive guidance document aimed at clarifying elements of the medical device pre-submission program, now used to provide manufacturers and application sponsors with feedback and advice.

Those meetings are crucial to identifying, clarifying and mitigating any issues with a clinical trial or full medical device application, which can be delayed or derailed entirely by regulatory issues. The meetings, then, are a way for industry to identify regulatory efficiencies and for FDA to save review resources for where they are needed most.

But by virtue of the fact that the pre-submission program and its various meetings encompass nearly every conceivable problem and type of interaction, FDA's guidance on its topic isn't typical. Whereas most guidance documents weigh in at around 10-20 pages, FDA's Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staffweighs in at a massive 53 pages.

Within the guidance is information on when to submit information to FDA, what information to submit, how FDA provides feedback, the logistics of meeting with FDA and which meeting types to request.

Also included in the guidance are various appendixes clarifying various issues associated with specific types of applications, including Investigational Device Exemptions (IDE), 510(k)s, premarket approval applications (PMA), humanitarian device exemptions (HDE) and In Vitro Diagnostic (IVD) applications. Also included are details about pre-submission meetings for non-significant risk (NSR) devices, which are exempt from FDA's usual premarket approval standards.

The pre-submission program was formerly known as the Pre-IDE program, and FDA wrote in its accompanying Federal Register notice that the new guidance is intended to provide industry with updated expectations that reflect the "broader scope" of the program, including new medical device co-regulated by the Centers for Devices and Radiological Health (CDRH) and Biologics Evaluation and Research (CBER).

The draft version of the guidance was released in July 2012.


Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff

Federal Register Notice

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