FDA Issues Final Rule on Appeals of Medical Device Decisions

In 2012, as part of the FDA Safety and Innovation Act (FDASIA), Congress required the FDA to furnish, upon request, a “substantive summary of the scientific and regulatory rationale for any significant decision” made regarding medical devices by the FDA’s Center for Devices and Radiological Health (CDRH). In particular, the rules affected decisions related to a 510(k) premarket notification, premarket approval (PMA), humanitarian device exception (HDE), and investigational device exception (IDE). The FDASIA also established certain time frames for supervisory reviews of such decisions. The FDA issued two guidance documents discussing these requirements and a final rule to implement them.