Getting Devices to Market Faster
Learn how the FDA is making it easier for healthcare officials and patients to access new medical devices
The FDA is making it easier for healthcare officials and patients to access new medical devices.
The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It speeds up development, assessment and review for premarket approval.
The Breakthrough Devices Program allows manufacturers to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect a prioritized review of their submission.
The program includes devices subject to premarket approval applications, premarket notification or requests for De Novo classification. The devices must also provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions, represent breakthrough technology and meet at least one of these conditions:
- No approved or cleared alternatives exist
- Offer significant advantages over existing approved or cleared alternatives
- Device availability is in the best interest of patients
A new expansion
The FDA’s Center for Devices and Radiological Health (CDRH) launched the voluntary Total Product Life Cycle Advisory Program (TAP) Pilot to help spur more rapid development of high-quality, safe, effective and innovative medical devices that are critical to public health. The TAP Pilot is one of the commitments between the FDA and the industry as part of the MDUFA V reauthorization.
In October, the FDA will expand its use of the TAP program to include devices reviewed by the Office of Radiological Health and the Division of Ophthalmic Devices.
Read more about TAP in this article. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.
At ASG, we specialize in helping clients streamline regulatory approvals. That’s why we stay up to date on the latest regulatory standards for medical devices in the United States and Europe. Read more here.
