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Frequently Asked Questions

What is 510k FDA approval?

FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

What is 510 k process?

FDA’s 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. It provides FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices.

What is a traditional 510 k?

Introduction. A 510 (k) is a document containing information required under 21 CFR 807 Subpart E. All 510 (k)s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. All 510 (k)s provide a comparison between the device to be marketed and the predicate device or devices.


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