The Medical Device Review Process: A Focus on Pre-Market Requirements

October 2012

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by Michele L. Buenafe, Esq.

The Medical Device Review Process: A Focus on Pre-Market Requirements Primer will explain, in practical terms, the medical device approval process. The publication walks readers through the process of determining whether a product qualifies as a medical device, describes the various FDA premarket requirements, and details the numerous pathways for bringing a medical device to market, including 510(k) applications, Premarket Approval Applications (PMAs), Investigational Device Exemptions, Humanitarian Device Exemptions, and Custom Devices. This Primer will also provide the reader with a summary of changes enacted under the Food and Drug Administration Safety and Innovation Act (FDASIA).  With this Primer, medical device stakeholders will feel confident that they can successfully navigate the complicated FDA medical device review process.


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