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Frequently Asked Questions

When to submit a new 510(k)?

After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510 (k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.

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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