How to Transfer Ownership of a 510(k) Clearance

April 1, 2000By: Jeffrey K. Shapiro Download PDF

Many medical devices require 510(k) clearance or premarket application (PMA)

approval from FDA prior to commercial distribution. A firm that is purchasing or licensing medical device technology already on the market needs to make certain that the deal also includes a valid transfer of the 510(k) clearance or

PMA approval to assure that commercial distribution can be lawfully continued. The FDC Act and implementing regulations are silent on such transfers.

However, historically, FDA has permitted them.

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