The United States (US) Food and Drug Administration (FDA) has updated guidance on how to utilise its Q-Submission program for medical device manufacturers before they submit premarket applications. The purpose of the draft guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or request a meeting with the FDA prior to submitting premarket applications.
The FDA has updated their Q-Submission program in accordance with the Medical Device User Fee Amendments of 2017 (MDUFA IV), which set new requirements regarding pre-submission meeting scheduling and feedback times.
The draft guidance discusses four options that are available to applicants under the FDA Q-Submission program, including pre-submissions, submission issue requests (SIRs), study risk determinations (SRDs) and information meetings. Q-Submission meetings can cover premarket approval (PMA) and 510(k) premarket notification applications, humanitarian device exemption (HDE) and De Novo requests, as well as investigational device exemption (IDE) questions for clinical investigations.
The guidance states that a pre-submission “is appropriate when FDA’s feedback in specific questions is necessary to guide product development and/or submission preparation”. The pre-submission option entails a written request from a market registrant for written feedback from the FDA, with or without a face-to-face meeting to discuss the request. Manufacturers may use SIRs to request feedback from the FDA on how to address hold letters, which are issued when the FDA requires further information for premarket applications or they identify deficiencies in such applications.
SRDs apply to cases where clinical study sponsors require FDA determinations on whether planned clinical studies pose a significant or non-significant risk, or if studies are exempt from IDE regulations.
For any type of Q-Submission preparation, the draft guidance recommends that the following should be included in the submission to the FDA: Submitter’s contact information; type of Q-Submission request; proposed meeting agenda, format and preferred dates and times; purpose of the Q-Submission, including goals for the outcome of an FDA interaction; device description and proposed indications for use or intended use, and regulatory history of the device in question.
The draft guidance also includes further recommendations that are specific to each type of Q-Submission, plus submission checklists and sample questions from manufacturers.
To view the draft guidance from the FDA on the Q-Submission program, please click here.