This bill amends the Federal Food, Drug, and Cosmetic Act to replace the requirement that the Food and Drug Administration (FDA) prioritize review of breakthrough medical devices with a requirement that the FDA establish a program to provide priority review for breakthrough medical devices.
Prior to submitting an application for approval, a medical device sponsor may request that the FDA designate the medical device for priority review. The FDA must provide a summary of the basis for its determination regarding designation.
To expedite the development and review of designated medical devices, the FDA must:
- assign a team of staff for each device,
- adopt an efficient process for dispute resolution,
- provide for interactive communication with the device sponsor,
- expedite review of manufacturing and quality systems compliance,
- disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts,
- assign staff to address questions by institutional review committees concerning investigational use of the device.
The FDA may: (1) coordinate with the sponsor regarding early agreement on a data development plan; (2) take steps to ensure that the design of clinical trials is as efficient as practicable; (3) utilize timely postmarket data collection; and (4) agree to clinical protocols, subject to an FDA determination that changes are required to prevent an unreasonable risk to the public health or that a substantial scientific issue is essential to the safety or effectiveness of the device.