FDA Medical Device Q-Submission : Preparation and Review
Aug 10 2022
The Q-Submission Program allows manufacturers of medical devices and in vitro diagnostic devices to obtain feedback on the regulatory process and requirements for devices they have in development.
It requires to share information with FDA and receive input outside of the submission of an IDE, IND, marketing submission, or CW. Q-Subs can serve as helpful tools in the premarket submission process and FDA reviewers are encouraged to work interactively 28 with submitters while the Q-Sub is under review to fully utilize this process.
The interactions tracked in the Q-Sub program may be used at different points along the total product life cycle for a device and are voluntary. For example, in a given product’s development cycle, a submitter may wish to conduct an Informational Meeting, followed by a request for Breakthrough Device Designation, with later discussions to refine specific aspects of non-clinical and clinical testing through Pre-subs. Tracking these interactions as Q-Subs facilitates review and serves to document interactions for the record.
However, the number of Q-Subs and Q-Sub supplements submitted should be carefully considered to avoid confusion and unnecessary expenditure of both FDA and industry time and resources.
The Q-Sub program is not meant to be an iterative process, i.e., one in which FDA considers the same or similar information more than once. If you intend to submit more than one Q-Sub to request discussion and/or feedback on additional topics for the same device, we suggest that your initial Q-Sub contain an overview of your expected submissions, including general time frames, if known. The intent is for FDA and the submitter to focus on the submitter’s current priority. As such, for any given device, only one Q-Sub should be submitted at a time. A Q-Sub cannot be withdrawn after feedback is provided and the file is closed; however, there is no requirement for a follow-on premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), CW, Dual, Request for Accessory Classification, IND, or BLA).
1. Submission Content
To ensure appropriate log in and to facilitate review of a Q-Sub, the following should be included in a Q-Sub Cover letter. Your Q-Sub should be written in the English language.
Device or Product Description
Proposed Indications for Use or Intended Use
The FDA review clock starts when a valid eCopy is received; however, for Q-Subs that utilize an acceptance review, if a file is placed on hold, the review clock will begin upon receipt of the amendment that is accepted for review.
2. FDA tracking
FDA assigns a unique identification number to all Q-Subs as described below.
Meetings allow for an open discussion and exchange of technical, scientific, and regulatory information that can help build a common understanding of FDA’s views on clinical, nonclinical, or analytical studies related to an IDE, or marketing submission.
How to prepare the meeting with FDA?
Provide several options for meeting dates
Confirm meeting details with RPM
Prepare Presentation : It requires you to send it to FDA at least three business days prior to meeting.
Limit the meeting to 1 hour
Allow time for discussion
Take detailed notes (bring a dedicated attendee)
Ask for clarification if needed
Summarize action items at the close of the meeting
Expect FDA to act as a consultant (FDA doesn't discuss data)
Expect that FDA clear/approve/license a device at the meeting
Send new questions or discussion topics at the last minute
Q-Sub types and corresponding feedback mechanisms and timelines
Method of Feedback
Timeframe for Sending Feedback or Scheduling Meeting (from receipt of submission)
- Meeting (face-to-face or teleconference) with written feedback provided in advance - Written Feedback Only
Written Feedback: 70days or 5 days prior to scheduled meeting, whichever is sooner Meeting: Date based on mutual agreement (typically at 60-75 days)
Submission Issue Request (SIR)
Meeting or Written Feedback
- If SIR is received more than 60 days of FDA's marketing submission letter: 21 days as resources permit - If SIR is received more than 60 days after FDA's marketing submission letter: 70days as resources permit
Study Risk Determination
* When used to track requests that do not meet the definition of a Q-Sub type, Informational Meeting timeframe and feedback mechanism can vary. Typically, informational meetings do not inclue FDA feedback.
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