The FDA’s Center for Devices and Radiological Health (CDRH) has launched the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) to help spur more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health.
TAP’s primary goal is to expedite patient access to innovative medical devices by providing early, frequent and strategic communications with the FDA and by facilitating engagement with other key parties for developers of devices of public health importance. To achieve this goal, FDA TAP advisors proactively provide solutions-focused engagement tailored to each TAP participant’s needs in advancing devices to market and patient access.
With TAP, the FDA is striving to play a more active part in supporting patient access to innovative, safe and effective devices.
TAP is currently accepting enrollment requests for medical devices reviewed by the Office of Cardiovascular Devices (OHT2) and Office of Neurological and Physical Medicine (OHT5). Beginning October 1, 2024, the TAP Pilot will expand to include the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A). On January 1, 2025, the TAP Pilot will also expand to include the Office of Orthopedic Devices (OHT6).
Webinar Highlights:
- Learn how TAP is designed to help address challenges in the medical device life cycle.
- Understand how TAP advisors support participants by facilitating proactive and strategic engagements with FDA and non-FDA parties.
- Accelerated FDA engagement options.
- Enrollment criteria and expansion.
Speakers:
Kiyana Weatherspoon, MS
Lead Reviewer
Total Product Life Cycle Advisory Program (TAP)
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Laura Gottschalk, PhD
TAP Advisor
Total Product Life Cycle Advisory Program ( TAP)
Center for Devices and Radiological Health
U.S. Food and Drug Administration
