German medtech MDR to FDA bridge.
The corridor view. What carries from an MDR file into a US 510(k) submission, and what has to be rebuilt for FDA.
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The FDA Center for Devices and Radiological Health (CDRH) framework for voluntary pre-submission interactions between medical device sponsors and the agency, used to request feedback before formal filings.
The Q-Submission Program is administered by the FDA Center for Devices and Radiological Health (CDRH) and provides multiple submission types under a common procedural umbrella for sponsor-FDA interactions ahead of, or alongside, formal regulatory filings. The program is voluntary and is widely used to reduce regulatory uncertainty before significant resources are committed to a 510(k), De Novo, PMA, IDE, or HDE submission.
Principal Q-Sub types include the Pre-Submission (Pre-Sub) for feedback on planned testing, indications, predicate selection, or pathway choice; the Submission Issue Request (SIR) for issues that arise during the review of a pending submission; the Study Risk Determination for IDE risk classification of a planned clinical investigation; the Informational Meeting for general device feedback without specific FDA decisions requested; and the Agreement Meeting and Determination Meeting for binding or quasi-binding agreement on specific topics within the PMA framework. Each type follows defined content and procedural expectations set out in the CDRH guidance Requests for Feedback and Meetings for Medical Device Submissions.
FDA Pre-Sub feedback is typically delivered within 70 to 90 FDA days, in the form of written responses, a teleconference, or a meeting at FDA's offices, depending on the requested format. Pre-Sub feedback is not binding on either party but is generally treated as the working basis for subsequent submission planning. Pre-Subs are particularly useful for novel device designs, unclear pathway selection, software-as-a-medical-device (SaMD) classification questions, AI/ML feature evaluation, and early discussion of clinical study design before IDE submission.
For a European manufacturer with an MDR CE mark and an open question about whether a US predicate exists, whether a feature triggers De Novo, or whether US-specific testing differs from EU testing, a Pre-Submission is the most efficient instrument for resolution. The corridor view of MDR-to-FDA bridge work is in the German medtech MDR-to-FDA bridge pillar.
For firms operating in adjacent regulated categories where pathway choice is unclear, the Pre-Sub is the lowest-risk way to obtain FDA feedback before committing to a submission strategy.
The corridor view. What carries from an MDR file into a US 510(k) submission, and what has to be rebuilt for FDA.
Read the pillar →The Premarket Notification submission demonstrating substantial equivalence to a US predicate device.
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