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Today, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is announcing that breakthrough designated devices reviewed in the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A) are eligible to enroll in the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.
Additionally, CDRH is providing a resource for innovators and collaborators: TAP Pilot Engagement Tips that is intended to provide considerations that may help foster productive engagement between medical device sponsors and non-FDA parties including patients, payers, and health care providers during the medical device design and development process.
CDRH launched the TAP Pilot in 2023 as a commitment under the Medical Device User Fee Amendments (MDUFA) V reauthorization to help spur faster development of high-quality, safe, effective, and innovative medical devices that are critical to meeting public health needs. To date, the TAP Pilot has enrolled 52 Breakthrough Designated Devices in the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5).
Questions?
If you have questions about TAP, contact TPLC-Advisory-Program@fda.hhs.gov.
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