New FDA Guidance Provides Insight into Premarket Approval Process

Recently, FDA provided an inside look at how it reviews medical devices for premarket approval. On March 27, the agency released “Guidance for Industry and Food and Drug Administration Staff: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De NovoClassifications.” This document provides insight into the factors the agency considers when it assesses certain diagnostic and therapeutic medical devices for premarket approval (PMA) or de novo classification decisions. According to the agency, “FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.”

The new guidance addresses only PMA and de novo submissions; it does not address 510(k) decisions. PMA is the scientific and regulatory review process used to determine the safety and efficacy of Class III devices (i.e., high-risk devices) before these products enter the market. The de novo process allows certain low- to moderate-risk medical devices to receive expedited review for possible designation as Class I or Class...