510(K) Pre-Submission

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A Q-Submission process (Q-Sub for short) is a path to request different types of medical device submission-related communications with the FDA.Q-submission includes the following types of requests for feedback from the FDA,

Pre-submission meetings:

A Pre-Sub includes a formal written request from a submitter for feedback from the FDA before an intended premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND), Accessory Classification Request, or CW.

The feedback is provided in the form of a formal written response or if the submitter chooses, formal written feedback followed by a meeting in which any additional feedback, or clarifications are documented in meeting minutes. Such a Pre-Sub meeting can be in-person or by teleconference as the submitter prefers.

A Pre-Sub should contain clear, specific questions regarding review issues relevant to a planned IDE, CW, IND, or marketing submission to focus FDA and submitter efforts on issues most relevant to moving a project forward.

It is critical to ask targeted questions in FDA 510k Pre-Submission applications. If questions are vague, it is difficult to obtain valuable feedback from the FDA. Most importantly, during Pre-Submission meetings, company sponsors are advised not to discuss topics that are not included in their corresponding Pre-Submission applications; however, the extent to which this is enforced may vary from one review team to another and may depend on the existing relationship between company representatives and the FDA review team.

Submission Issue Requests (SIRs):

SIR is a request for FDA feedback on a proposed approach to address issues conveyed in a Marketing Submission (i.e., PMA, HDE, De Novo request, 510(k), Dual, or BLA) hold letter, a CW hold letter, an IDE Letter, or an IND Clinical Hold letter. The SIR is intended to facilitate interaction between FDA and the submitter to quickly resolve or clarify issues identified in these letters so that projects can move forward, and so that submitters can fully address outstanding questions and issues in their formal responses.

Study Risk Determination:

A Study Risk Determination is a request for FDA determination for whether a planned medical device clinical study is significant risk (SR), non-significant risk (NSR), or exempt from IDE regulations as defined by the IDE regulations (21 CFR part 812).

Informational meetings:

An Informational Meeting is a request to share information with FDA without the expectation of feedback. This information sharing can be helpful in providing an overview of ongoing device development (particularly when there are multiple submissions planned within the next 6-12 months) and familiarizing the FDA review team about new device(s) with significant differences in technology from currently available devices. While FDA staff may ask clarifying questions during an informational meeting, they will generally be listening during the meeting and not prepared to provide any feedback.

Informational Meetings can also be used to document FDA and submitter interactions that do not fall within the definition of the other types of Q-Submissions.

Other Q-Submission Types:

Currently, in addition to the Q-Sub types above, the interactions that are tracked in the Q-Submission program include the following:

PMA Day 100 Meetings as described in FDA’s guidance entitled “Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies.”

Agreement and Determination Meetings as described in FDA’s guidance entitled “Early Collaboration Meetings Under the FDA Modernization Act (FDAMA).”

Submissions associated with the Breakthrough Devices Program as described in FDA’s guidance entitled, “Breakthrough Devices Program.

Submissions associated with the Safer Technologies Program (“STeP”) as

described in the FDA’s guidance entitled, “Safer Technologies Program for Medical

Devices”

Accessory Classification Requests as described in FDA’s guidance entitled,

“Medical Device Accessories – Describing Accessories and Classification

Pathways”

Recommended Information for Pre-Submission

Cover Letter
CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)
Table of Contents
Detailed Device Description
Proposed Intended Use/Indications for Use
Summary of Previous Discussions or Submissions Regarding the Same Device
Overview of Product Development
Specific Questions for FDA Feedback
Preferred method to receive FDA Feedback
Meeting Format, Preferred Dates and Times, Planned Attendees, and

Audiovisual equipment is needed if a meeting or teleconference is requested.

Pre-Submission review process

Once a Pre-Submission application is submitted, the FDA review team has 15 days to accept or deny using the acceptance checklist in the Q-Submission guidance document.

If denied, the Agency will notify the submitter with an explanation. The submitter is permitted to respond with a Q-Submission Amendment.

If an application is accepted, the agency has 30 days to schedule an in-person meeting or conference call. The submitter should receive written feedback within 70 days or at least 5 days before their scheduled meeting with the FDA review team, whichever comes first.

In-person meetings and conference calls are limited to one hour, but the submitter can request additional time if needed.

Following the meeting or conference call with Agency staff, the submitter is responsible for drafting meeting minutes. These minutes must be submitted to the Agency for review within 15 calendar days of the meeting date.

If no revisions are needed, the meeting minutes become final once the FDA communicates this information to the submitter.

On the other hand, if the Agency chooses to revise the draft minutes, FDA staff will send an updated copy to the submitter within 30 days. In this case, the minutes become the final 15 days after the submitter receives the FDA’s edits.

Advantages of Pre-submission

The advice provided by the FDA before the 510k submission can be very useful in streamlining the review and determination of substantial equivalence.

It provides better clarity on subject device requirements.
It helps to improve the quality of the final 510k file,
It enhances the transparency of the review process,
It results in smooth and clear review comments,
It helps to potentially shorten the total review times,
There is no fee required for this submission.

Conclusion

Prep-submission helps manufacturers, primarily obtain the FDA’s feedback before generating data for the 510(k) submission about the device’s safety and effectiveness. Contact the I3CGLOBAL team for more information.