FDA Releases Guidance on Resolving Scientific Disputes Concerning Medical Device Regulation

Summary

The Food and Drug Administration (FDA) has released a guidance document titled "Resolving Scientific Disputes Concerning the Regulation of Medical Devices," which outlines the process for resolving scientific disputes related to medical device regulation. The document explains the role of the Medical Devices Dispute Resolution Panel, a committee established by the FDA, and provides guidance on how to submit a request for review.