Medtech Matters
Medtech Matters
Medical Product Outsourcing
FDA's Third-Party Review Program
1 hour 1 minutes Posted May 14, 2026 at 2:00 pm.
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s third-party review program. This option is available for certain 510k reviews. It is performed through an independent organization that is not part of the agency. As such, there are additional costs involved but the time savings could potential make up for that added expense. Other factors and considerations are also reviewed. During this conversation, the fol...