Best practices for navigating your medical device 510(k) regulatory strategy and submission plan
The medical device industry knows that obtaining marketing clearance from FDA for a premarket submission (510(k)) can be challenging, time-consuming, and expensive. While most firms/sponsors are aware of the FDA Pre-Submission Program, many think its use is too time consuming (with a mandated 70-day review timeline) and that it may be quicker and simpler just to prepare and submit a 510(k) without it, so long that an appropriate predicate is determined and relevant performance and safety testing is completed.
FDA implemented the Q‑Submission Program which is better known as a “Pre-Submission or Pre-Sub” to help align the medical device industry with FDA current requirements and review objectives. A Pre-Sub is the official mechanism for medical device sponsors to request formal feedback or a meeting with FDA review staff before a 510(k), PMA or other regulatory premarket submission. This program was established in 1995 as the Pre‑IDE Program and expanded under the FDA Safety and Innovation Act (FDASIA) of 2012, with the current May 2025 final guidance titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” supplanting earlier versions.
As of June 1, 2026, FDA requires that all Pre-Subs must be developed into the PreStar pdf format (link here) and submitted via the FDA’s Customer Collaboration Portal (CCP). The good news for a Pre-Sub is that it is free to submit, since no user fee is required. However, all Pre-Sub submissions must be well planned and executed, and considerable time should be spent preparing them properly. In the Pre-Sub, your medical device must be fully described including a proposed intended use and any potential or likely predicate devices, which helps guide a regulatory pathway strategy and allows the appropriate FDA reviewer to evaluate the Pre-Sub questions. Optional but recommended, the Pre-Sub may include draft labeling, as it is very valuable to get feedback on this as early, if possible, as changes are usually always requested by FDA in additional information requests to the premarket submissions.
Looking forward into the future FDA plans, in a Federal Register published post about a public meeting regarding the Medical Device User Fee Amendments (MDUFA) VI reauthorization (for the fiscal year 2028-2032) there is the introduction of the concept of “Focused Follow-Up Pre-Submissions—a new, faster-turnaround submission type intended to address targeted follow-up questions related to a prior Pre-Submission, with a written response provided within 45 calendar days of receipt. In conjunction with the proposed enhancements and performance goals outlined in the draft commitment letter, FDA and industry agreed to proposed changes to the FD&C Act to include a fee (estimated at $2,000 USD) for initial Pre-Submissions, to promote efficient use of the program, and for which sponsors will later receive a corresponding credit on certain related subsequent marketing submission fees.”
A Pre-Sub must be a well-thought-out document so that sponsors receive an adequate and sufficient FDA review and feedback. FDA’s feedback will help the Sponsor avoid some of the future pitfalls in any a future 510(k) or other planned premarket submission.
There are some important limitations of a Pre-Submission that all sponsors need to be aware of:
- FDA does not accept any data or reports
- FDA only allows up to 4 key topics in a Pre-Sub
- FDA requires less than 10 total specific questions in a Pre-Submission (can be split any way between the 4 categories)
For example, if the Sponsor focuses on 2 topics areas, within each of the two topics, the firm will only be allowed up to five (5) specific questions.
In order for FDA to adequately evaluate each question, the Pre-Sub must provide adequate content and/or attachments for additional support in that specific topic area. Questions need to focus on any of the following key topics (organized by major theme by ACI):
General Regulatory Strategy
- Regulatory Strategies – to confirm pathway and/or appropriate predicate
- Indications for Use/Intended Use
- Device Description or New Technologies
- Labeling Questions
- Predetermined Change Control Plans
Clinical Testing and Studies
- Clinical Studies – Note: FDA will review study plans or protocols
- Real World Data/Real World Evidence
- Statistics
- CLIA Waiver Study Design
- Clinical Outcome Assessment (COA), Patient Reported Outcome (PRO) and/or Patient Preference Information (PPI)
Non-Clinical Testing and Studies
Note: FDA will only review study plans or specific protocols
- Non-Clinical Benchtop Performance Testing
- Animal Studies
- Reprocessing, Sterilization & Shelf Life
- EMC & Electrical/Mechanical/Thermal Safety
- Biocompatibility
- Human Factors
- Software/Firmware
- Wireless Technology
- interoperability
- Cybersecurity
Whenever, Accurate Consultants/ACI starts to draft a Pre-Sub, we first recommend to brainstorm, formulate and document key questions that need to answered based on the development so far of the medical device. Then once these are determined, we take those questions and rate them for importance and relevance. The relevant questions are then grouped into the appropriate topics. Focus on high‑risk regulatory, pre-clinical, or clinical questions. Use specific, open‑ended questions that invite FDA to agree or disagree with the firm’s premise. Prepare supporting data for each question. Consider FDA’s terminology and quote all applicable and relevant Guidance documents or standards.
Some key considerations to keep in mind (and to avoid):
- Don’t ask open-ended questions. Avoid asking “What testing should we do?” frame your question as “We propose X testing because of Y. Does the FDA agree?”
- Don’t hide any potential risks. If your device uses novel materials or unique software algorithms, address them upfront, don’t wait for FDA to find them.
- Don’t treat FDA feedback as a guarantee. Written feedback is non-binding and can change if new safety data emerges or if guidelines are updated before your final submission.
- Don’t submit test reports, only test protocols and make sure they are complete with a rationalized acceptance criteria and defined sample sizes.
Sources
Department of HHS. Federal Register notice – Medical Device User Fee Amendments; Public Meeting; Request for Comments. Posted 7/7/2026. https://www.federalregister.gov/d/2026-13778
PreStar – electronic Submission Template and Resource (eSTAR) For Early Submission Requests – Version 3.0 (06-01-2026)
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff, Issued May 29, 2025