CDRH issues final rule on appeals, excluding De Novos from 517A

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two accompanying guidance documents related to appeals.

Most notably, while acknowledging the importance of De Novo decisions, FDA declined to expand the definition of "517A decisions" to include the grant or decline of a De Novo request, despite comments to the proposed rule that requested such an expansion, citing the language in the statute. FDA also issued an updated guidance on appeals that reflects the final rule and includes additional updates, such as inclusion of a section indicating the process should not be used to raise allegations of bias or retaliation. The appeals guidance further notes that the agency intends to follow 517A time frames for non-517A appeals as well; however, this is a nonbinding commitment and it remains to be seen how the Center for Devices and Radiological Health (CDRH) will handle the timing of non-517A appeals, particularly those related to De Novo decisions.

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