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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 A Q-Sub cannot be withdrawn after feedback is provided and the file is closed; however, there is no requirement for a follow-on premarket submission (i.e., IDE, PMA, HDE, De Novo request,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).




Q-Submission Processes



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.

  • Contact Information

  • Q-Sub Type

  • Purpose

  • Device or Product Description

  • Proposed Indications for Use or Intended Use

  • Regulatory History

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.

  • Original

  • Supplement

  • Amendment


3. Meeting

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.


Do

  • 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


Don't

  • 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

Q-Sub Type

Method of Feedback

Timeframe for Sending Feedback or Scheduling Meeting (from receipt of submission)

Pre-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

Formal Letter

​90 days

Informational Meeting*

Meeting

90 days

* 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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SOURCE :

www/fda.gov/regulatory-information/requests feedback and meetings medical device submissions