USA – US FDA issues final rule for appealing medical device regulatory decisions

A final rule recently issued by the US Food and Drug Administration explains procedures and timeframe requirements whereby regulatory decisions by the agency’s Center for Devices and Radiological Health (CDRH) may be appealed.

The final rule follows draft guidance in late 2017 as well as a proposed rule  in early 2018, adding additional procedures for how US medical device premarket applicants may appeal some CDRH regulatory decisions. Implementation of these procedures, expected in August 2019, were stipulated by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the 21stCentury Cures Act of 2016.

FDA argues that the final rule provides more transparency for both medical device market applicants and CDRH staff in terms of how supervisory reviews of decisions should be handled, as well as a more predictable process and clear deadlines for agency responses to appeals…