FDA 510(k) Database

In the United States, most new medical devices are launched through the FDA’s 510(k) clearance process. Device manufacturers must take advantage of the FDA database for 510(k) clearances if they are planning to make any equivalence claims.

If your company is developing a product similar to a medical device that already exists, you must search in the FDA 510(k) database for the predicate device most similar in characteristics and indications to your product.

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