FDA Pre-Submission Meeting Types Explained

The FDA Pre-Submission (Pre-Sub) program is one of the most underutilized regulatory tools available to device manufacturers. By requesting formal FDA feedback before investing in a pivotal clinical study or a full premarket submission, manufacturers can identify and resolve scientific and regulatory issues early — when the cost of course-correction is low rather than high.

The Q-Submission Program consolidated several earlier FDA feedback mechanisms into a single, unified process tracked under "Q-Sub" designations. Understanding the different types of requests within the program helps manufacturers select the right format for their specific question.

Standard Pre-Submission (Q-Sub)

The standard Pre-Submission request — often called simply a "Pre-Sub" or "Q-Sub" — is the most common type. It is used to request FDA feedback on a regulatory or scientific question before a formal submission is filed. A Pre-Sub can cover:

• Device classification and proposed regulatory pathway
• Proposed clinical study design: primary endpoints, comparator, statistical approach, sample size rationale
• Bench testing and biocompatibility strategy
• Software and cybersecurity documentation plans
• Proposed 510(k) predicate selection and substantial equivalence strategy
• De Novo classification request content and proposed special controls
• Human factors study design and usability testing approach

A Pre-Sub can result in either a written response from FDA (for straightforward questions that don't require a meeting) or a teleconference or in-person meeting followed by meeting minutes. Manufacturers should propose specific, closed-ended questions rather than open-ended inquiries — "Does FDA agree that our proposed clinical protocol's primary endpoint is adequate to support 510(k) clearance?" is the right format; "What do you think of our study design?" is not.

Pre-IDE Meeting

A Pre-IDE (Pre-Investigational Device Exemption) meeting is a specific type of Pre-Sub used when a manufacturer plans to conduct a clinical investigation of a significant-risk device in the United States and needs an IDE from FDA before beginning the study. A Pre-IDE meeting focuses specifically on the proposed clinical investigation design — the protocol, safety monitoring plan, endpoints, and IDE submission content — rather than the broader device classification or regulatory pathway.

Pre-IDE meetings are particularly valuable because IDE submissions that are deficient or poorly designed may receive a Disapproval or a conditional Approval with extensive conditions. A Pre-IDE meeting allows FDA and the sponsor to align on study design expectations before the IDE is filed, reducing the probability of a conditional approval that requires protocol amendments before enrollment can begin.

Informational Meeting

An Informational Meeting is a Pre-Sub variant that a manufacturer uses to provide FDA with background information about a technology area, an emerging clinical use, or a novel device concept — without necessarily asking specific questions or requesting formal written feedback. Informational meetings are often used early in product development to gauge FDA's familiarity with a technology and to introduce the manufacturer's program before any formal submissions are planned.

While informational meetings do not produce binding FDA feedback in the same way a Q-Sub does, they can be valuable for building a productive relationship with the relevant CDRH division, surfacing potential regulatory concerns early, and informing the manufacturer's development strategy before major investments are made.

Submission Issue Request (SIR)

A Submission Issue Request (SIR) is a Q-Sub type used during an active premarket review — after a 510(k), De Novo, or PMA has been submitted — to request focused FDA feedback on a specific issue that has arisen during the review. Unlike a standard Pre-Sub (which occurs before any formal submission), a SIR occurs while a submission is under active FDA review.

SIRs are most useful when a reviewer's question or concern can be resolved through a targeted discussion rather than a full Additional Information (AI) response cycle. For example, if a 510(k) reviewer questions whether a specific performance test is necessary, a SIR can be used to discuss the issue directly with the review team before drafting a full AI response. Not all review divisions accept SIRs, and SIR requests must be narrow in scope and closely tied to an active review.

Written-Only vs. Meeting Formats

Manufacturers can request Pre-Sub feedback in two formats: written-only or meeting (teleconference or in-person). Written-only responses are appropriate when the questions are clear, well-documented, and can be answered from the record without discussion. Meeting formats are better suited for complex or nuanced questions where real-time dialogue would help the manufacturer understand FDA's feedback and ask follow-up questions in the moment.

If a meeting is requested, FDA will schedule a teleconference (most common) or an in-person meeting (less common and typically reserved for particularly complex or novel devices). The manufacturer submits a background package in advance that FDA reviewers read before the meeting. The meeting itself typically lasts 60–90 minutes and is followed by meeting minutes (FDA draft, manufacturer review, FDA finalization) that become the official record of the FDA feedback.

How to Choose the Right Request Type

For most manufacturers seeking feedback before a formal 510(k), De Novo, or PMA submission, a standard Q-Sub is the correct format. Use a Pre-IDE meeting when the primary question concerns a clinical study design for an IDE submission. Use a SIR only when there is an active submission under review with a specific, bounded issue to discuss. Use an Informational Meeting when early-stage dialogue with FDA is the goal and no formal questions are ready yet.

In all cases, invest in drafting clear, specific, answerable questions. The quality of the FDA response is directly proportional to the quality of the questions asked.

Frequently Asked Questions

What is the difference between a Q-Sub and a Pre-Sub?

Pre-Submission (Pre-Sub) is the general name for the FDA program through which manufacturers submit written questions and request FDA feedback before filing a formal premarket submission. Q-Sub (Q-Submission) is the submission type code used to track a Pre-Sub request in FDA's tracking system. In practice, the terms are used interchangeably. A Q-Sub is a Pre-Sub submitted under the Q-Submission Program, which consolidates all voluntary feedback mechanisms into a single process managed by CDRH.

What types of questions can I ask in a Pre-Sub?

Pre-Sub questions can cover a wide range of regulatory and scientific topics, including: device classification and regulatory pathway; proposed clinical trial design (primary endpoints, sample size, statistical approach); biocompatibility and bench testing strategy; software and cybersecurity documentation approach; proposed 510(k) submission strategy; De Novo classification request content; and labeling or human factors study design. Questions must be specific and answerable — open-ended questions like 'What do you think of our device?' are not appropriate for a Pre-Sub.

What is a Submission Issue Request (SIR)?

A Submission Issue Request (SIR) is a type of Q-Sub used when a manufacturer has already submitted a premarket application (510(k), De Novo, or PMA) and encounters a specific issue during review that would benefit from a focused discussion with FDA before responding to an additional information request. Unlike a standard Pre-Sub (which occurs before any formal submission), a SIR occurs during an active review. It is used to resolve a discrete factual or scientific question without requiring a full AI response cycle.

How long does FDA take to respond to a Pre-Sub?

Under MDUFA commitments, FDA's goal is to provide written responses to Pre-Sub requests within 70 calendar days of receipt for written-only requests, or to hold an in-person or teleconference meeting within 70 days for meeting requests. FDA sends an acknowledgment letter after receipt and a meeting notification or written response letter within the MDUFA target timeframe. Complex Pre-Subs with multiple questions across several disciplines may take slightly longer if FDA needs to consult multiple review teams.