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Medical Devices / Regulatory Affairs / Submissions and Approvals

CDRH Proposes to Clarify all Appeal Decisions are ‘Significant’

Jan. 23, 2018
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The FDA issued a proposed rule that would clarify the CDRH decision appeal process and expand the scope of what would be considered a “significant decision.”

The proposed rule would apply to section 517A of the FD&C Act, which was amended by FDASIA in 2012 specifying procedures and timeframes for internal agency supervisory reviews of significant decisions made by CDRH staff, to allow interested parties outside of the FDA to request a review of an agency employee’s “significant decision” in an appeal attempt.

It would also expand the scope of what would be considered a “significant decision” to include all other CDRH decisions as the agency intends to stop using this term and use the terms “517A decision” and “non-517A decisions” instead.

“We do not want to imply that all other decisions of the agency that do not fall within section 517A of the FD&C Act are not significant,” the agency said.

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