FDA Pre-Submission

21 CFR 820 Consultants

FDA Pre- Submission process is used by the applicant to obtain feedback from FDA before actual submission for the 510(k) clearance.

A formal written application, including a cover letter with details of the device and submitter, pre-market review submission cover sheet (Form 3514), specific questions, and the type of requested feedback, should be sent to FDA.

The response provided by the FDA is generally written. But if required, face-to-face meetings or teleconference may also be requested.

This program can be used to inform the FDA review team about the specifics of the device and also to understand the potential hurdles to be crossed for the clearance.

The advice provided by FDA is binding until changes in circumstances make the advice void. Additional comments may also be provided along with the response to the queries.

Better quality of the subsequent 510(k) application, smoother review, and shorter review times are some of the benefits of this program. Also, this process is free of charge.

What situations we can apply to the Pre-Submission Program? Is the FDA Q-submission and pre-submission are same?

The FDA Pre-Submission shall be considered during the following scenarios:

  • During investigational / marketing application to update the review team of FDA on data of the device and to get the knowledge into natural obstructions for approval or clearance.
  • In case of the new device does not precisely fall under an established regulatory pathway [New analyte, technology, etc.] i,e particularly useful for novel technologies which do not have specific guidance documents/standards, of having an ambiguous regulatory pathway
  • While planning a study that shall support the future application.

Some of the advantages of FDA Pre-Submission are:

  • Increased transparency of the review process
  • Better quality of the subsequent application
  • Relatively shorter total review times
  • No fee
  • Smoother review process

Pre-Submission is a way for the industry to get the opinion from the FDA before the Submission of a premarket application [510K, PMA IDE, HDE, Lenovo, etc.]

The sponsor may furnish a pre-submission application to the FDA seeking responses to various questions about the marketing application or clinical trial design of their device. The submitter may solicit for teleconference, meeting, or written response accordingly. 

Q submission is a structured process for managing and tracking the interactions between the submitters and FDA about impending applications for approval or clearance, before their Submission. 

The changes is that the types of meetings like Informational Meetings, Study Risk Determinations, Formal Early Collaboration Meetings, Submission Issue Meetings, and PMA Day 100 Meetings will now fall under the same organizational structure as of pre-submissions. 

These meeting types will be given a “Q” number (i.e. Q160001) and will be referred to as Q submission.

A Q-Sub cannot be withdrawn after feedback is provided, and the submission file is closed. FDA will keep the Q-Subs as confidential.