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 Premarket Notification submission to the US Food and Drug Administration demonstrating that a medical device is substantially equivalent to a legally marketed predicate.
A 510(k) is a Premarket Notification submission to the US Food and Drug Administration under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 USC 360(k)), with implementing regulations codified at 21 CFR Part 807, Subpart E. It is the most common FDA pathway for medical devices, with approximately 3,500 510(k) clearances issued annually. The submission demonstrates that the proposed device is substantially equivalent to a legally marketed predicate device that does not itself require Premarket Approval (PMA).
Three categories exist. A Traditional 510(k) is the standard format. A Special 510(k) covers modifications to a sponsor's own previously cleared device where design controls support the change. An Abbreviated 510(k) relies on conformance to FDA-recognised consensus standards, special controls, or FDA guidance documents. The standard MDUFA review goal for a Traditional 510(k) is 90 FDA days, although total elapsed time is frequently longer due to FDA Additional Information requests, which place the submission on hold.
Required submission elements include device description, indications for use, comparison to the predicate (technological characteristics and performance), biocompatibility evaluation per ISO 10993 as recognised by FDA, sterilisation and shelf-life data where applicable, software documentation aligned with IEC 62304 and FDA software guidance, electrical safety and electromagnetic compatibility per applicable IEC 60601 series standards, and labelling under 21 CFR Part 801. Foreign manufacturers without a US facility must designate a US Agent under 21 CFR 807.40.
For a European manufacturer with an MDR CE mark seeking US market access, a 510(k) is most often the appropriate first pathway when a US predicate exists in the same product code. The MDR clinical evaluation file, the technical file, and the Notified Body audit history are useful inputs to the dossier, but they do not substitute for FDA-specific testing, predicate analysis, or US labelling. The corridor mechanics are detailed in the German medtech MDR-to-FDA bridge pillar and the broader cross-border medtech commercialization pillar.
Where no predicate exists, the De Novo classification request or PMA pathway applies instead. Where the pathway is unclear, a Pre-Submission interaction under the FDA Q-Submission Program can resolve it before formal filing.
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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