![United States: When Should A 510(k) Include Clinical Data? - Hyman, Phelps, & McNamara, P.C.](https://cdn.newsserve.net/ONPglobe256.png)
United States: When Should A 510(k) Include Clinical Data? - Hyman, Phelps, & McNamara, P.C.
Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission.
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