The FDA’s May 2025 guidance updates and expands the Q-Submission process, offering manufacturers detailed pathways for obtaining feedback before market submissions. Strategic use of this tool can significantly accelerate and de-risk regulatory approval.
The Q-Submission (Q-Sub) Program is a voluntary FDA framework enabling early interaction between device manufacturers and regulators. It facilitates written feedback or meetings on preclinical/clinical plans, regulatory strategy, device classification, and other pre-submission topics. While not a formal review, Q-Subs are instrumental in shaping submission success.
Q-Sub types
- Pre-Submissions (Pre-Subs): written feedback and/or meetings.
- Submission Issue Requests (SIRs): clarification following hold letters.
- Study Risk Determinations (SR/NSR): risk classification of planned clinical studies.
- Informational Meetings: no-feedback discussions.
- PMA Day 100 Meetings: formal milestone in PMA review.
Q-Sub benefits
- Shortens overall submission timelines.
- Clarifies expectations.
- Reduces major deficiencies.
- Optimizes clinical study design (MDR, ISO 14155 alignment).
- Supports smarter regulatory pathway planning.
Submission essentials
- Clearly define intended submission (510(k), PMA, IDE).
- Describe device, technology, and intended use.
- Formulate 7–10 focused questions.
- Include regulatory history and proposed meeting agenda.
- Submit via eCopy, CDRH Portal, or ESG/CBER DCC depending on product type.
FDA review timelines
| Q-Sub Type | Response Time |
| Pre-Sub | 70 days (written), ~75 for meetings |
| SIR | 21–70 days |
| Study Risk Determination | 90 days |
| Informational Meeting | up to 90 days |
| PMA Day 100 | Exactly 100 days |
Relevance to MDR compliance
Q-Submission facilitates alignment with MDR’s GSPR, PMS, and clinical evaluation, enables harmonized global trial planning and bridges compliance across EU and US submissions. Q-Submission is a high-value mechanism that strengthens FDA-manufacturer dialogue before formal review begins. It supports global regulatory convergence and is especially valuable for complex or innovative technologies.
Read about the Q-Submission program:
