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

01/2/2013

This Primer explains, in practical terms, the medical device review 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. Get instant access, download now.

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