A company that wants to market in the U.S. a Class I, II, or III device for which a Premarket Approval (PMA) is not required, must submit a 510(k) to the FDA unless the device is exempt from 510(k) requirements.
A 510(k) submission is a pre-market submission made to the 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 (21 CFR 807.92(a)(3)) that is not subject to PMA. The Food and Drug Administration added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission. The agency allows companies to submit a de novo classification request to the FDA for novel low to moderate risk devices without first being required to submit a 510(k).
Companies must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (pre-amendments device).
The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.
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We help medical device and IVD industries with 510(k) services covering: De Novo, Traditional, Abbreviated, and Special 510(k)s. Please meeting to show how we can assist you.