FDA opens TAP

Regulatory NewsRegulatory News | 03 January 2023 |  By 

The US Food and Drug Administration (FDA) has initiated a soft launch of its Total Product Lifecycle Advisory Program (TAP), which was negotiated under the latest Medical Device User Fee Amendments (MDUFA V) deal. The agency has updated its website with details about how to apply for the pilot program and its plans to expand the program over the next five years.
 
On 1 January, FDA launched its TAP pilot program that would allow sponsors to get feedback from external stakeholders such as physicians and insurers on how to bring successful products to market. The medtech industry was initially strongly resistant to the idea when it was proposed during the MDUFA V negotiations, but the agency argued it would help device and diagnostics sponsors better prepare their products for market. In the end, both sides agreed to do a soft launch of the TAP program rather than a full launch to test its feasibility. (RELATED: FDA will begin accepting breakthrough devices for TAP pilot in 2023, Regulatory Focus, 11 October 2022)
 
“The TAP Pilot is intended to demonstrate the feasibility and benefits of process improvements to the FDA’s early interactions with participants and stakeholders that support the vision for TAP,” FDA said. “The 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. A mature TAP is also intended to help ensure the sustained success of the Breakthrough Devices Program.”
 
FDA said it is taking a phased-enrollment approach to its TAP pilot program. During the first phase, the agency plans to enroll 15 sponsors during FY2023 through its Office of Health Technology 2 (OHT2):  Office of Cardiovascular Devices.
 
The agency notes the decision to start with OHT2 was in large part due to its experience working with sponsors on Early Feasibility Studies and on its Breakthrough Devices Program, which it hopes will be bolstered by the TAP Program.
 
In coming years, FDA said it plans to keep adding sponsors and health technology offices that oversee other types of products as it gains more experience. By 2027 the agency plans to include 325 devices in the pilot program to help it figure out the feasibility of launching a full-blown program.
 
Sponsors who want to be a part of the TAP pilot program this year must have already been granted a Breakthrough Device designation but won’t need to submit a pre-submission. Their device also needs to be in the early development phase, and each sponsor is only allowed to enter one device into the pilot program each fiscal year.
 
Sponsors who want to participate in the pilot program should amend their Q-submission under which they received Breakthrough designation to include “TAP Pilot Request for Enrollment” in the subject line and other identifying details according to FDA.
 
“The FDA encourages all stakeholders, including pilot participants, to provide feedback on the TAP Pilot,” said the agency. “Feedback may be submitted under docket number FDA-2022-N-2274 by January 9, 2023, at www.Regulations.gov.”

 

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