The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase of this voluntary initiative, called TAP Pilot Soft Launch, will be conducted during fiscal year (“FY”) 2023 with enrollment beginning on January 1, 2023.
The Agency committed to establishing the TAP Pilot as part of the MDUFA V reauthorization, and the Agency’s long-term vision for TAP is “to help spur more rapid development and more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance.” As part of the TAP Pilot, the FDA will provide strategic engagement for such devices by:
- Improving participants’ experiences with the FDA by providing for more timely premarket interactions
- Enhancing the experience of all participants throughout the device development and review process, including FDA staff
- Facilitating improved strategic decision-making during device development, including earlier identification, assessment, and mitigation of device development risk
- Facilitating regular and solutions-focused engagement early in device development between FDA review teams, participants, and other stakeholders, such as patients, providers, and payers
- Collaborating to better align expectations regarding evidence generation, improve submission quality, and improve the efficiency of the premarket review process
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