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Medical Devices / Regulatory Affairs

Hearing Elicits Details of Device-Related Bills for MDUFA Reauthorization

May 8, 2017

A House Health subcommittee hearing focused on four device-related measures members are considering attaching to MDUFA reauthorization and user fee legislation.

Perhaps most significant for device makers is H.R. 1736, which aims to modernize FDA’s device inspections process to increase consistency and transparency. The bill proposes standardized and enhanced processes, including between FDA and facilities—prior to, during, and after inspections.

Testifying on behalf of AdvaMed, Patricia Shrader, vice president of global regulatory affairs for Medtronic, said the legislation is particularly welcomed by industry in addressing communications with FDA inspectors.

Currently, if a company needs to make a correction as the result of an inspection, it has 15 days to submit a remediation plan to FDA, but “there is no such timeline for FDA to respond to the proposed plan of correction,” Shrader said.

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