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MassMEDIC Submits Comments on FDA 510(k) Draft Guidance

This week MassMEDIC submitted its comments on the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health’s draft guidance document relative to filing a 510(k) for changes to an existing device. This was in response to the request for comments as stated in the Federal Register notice Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device published in Fed. Reg. Vol. 78, No. 47 (March 11, 2013).

MassMEDIC’s comments on the FDA’s guidance can be found here.