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# FDA Launches TAP Pilot
- URL: https://www.fdaweb.com/fda-launches-tap-pilot/
- Published: 2022-10-11T12:00:00.000Z
- Updated: 2026-09-14T18:02:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152935

FDA says CDRH has launched its Total Product Life Cycle Advisory Program (TAP) pilot intended to “de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with CDRH, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more rapid development of high-quality, safe, effective, and innovative medical devices first in the world that are critical to public health.” An agency [statement](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eksa-mills-sa-de-cv-634706-10052022?ref=fdaweb.com) says the TAP pilot is part of the MDUFA 5 agreement that was signed into law on 9/30.

CDRH says it will take a phased-enrollment approach to TAP throughout the five years of MDUFA 5\. A TAP pilot soft launch will open on 1/1/23\. In the soft launch, CDRH will enroll up to 15 devices in the Office of Health Technology 2: Office of Cardiovascular Devices.

The statement says the TAP pilot will build on lessons learned from the breakthrough devices and early feasibility study programs as well as Center experience engaging with sponsors during the pre-emergency use authorization process for Covid-19.

The statement says the TAP pilot will include establishing a dedicated cadre of FDA advisors trained to provide proactive, dynamic, and strategic feedback and advice tailored to the specific needs of each developer who has a device in the program. “TAP pilot feedback can help developers improve the quality of their submissions, including a better understanding of FDA’s expectations regarding generating evidence to support submissions,” it says. “By providing medical device developers with earlier and more frequent interactions with FDA’s advisors and review teams, it will better enable prompt identification of device issues that might delay FDA’s authorization, so those issues can be addressed earlier in the development process and improve the chances of faster authorization.”