What's the difference between TAP Pilot and EFS?

[Mandy0528]

Since FDA will lauch the TAP Pilot in FY 2023-2027, we are considering to apply for TAP Pilot or EFS. We are confused about the TAP Pilot, and we have been designated with Breakthrough Device, and have subimitted one Pre-sub about EFS under the Breakthrough Device Program. So which way for us is the recommended?

Total Product Life Cycle Advisory Program (TAP)

The FDA is seeking requests for enrollment in the TAP Pilot

www.fda.gov

 

[EmiliaBedelia]

They're 2 different programs and not necessarily mutually exclusive. If you are already interacting with the FDA to execute an EFS, what different interactions would you be expecting from TAP? What are you intending to learn or get out of participating in either program? Note that the TAP acceptance criteria states that a TAP applicant will NOT have already submitted a presub after the breakthrough designation, so you may not even be able to apply at this point.

Note that TAP is a voluntary pilot program that FDA is running in order to solicit feedback. So, it may or may not be beneficial to you - if you anticipate having a lot of questions that you really want FDA input on, then the TAP program might be helpful, but if you already have a strategy in place and you already have interactions via q-sub, EFS, etc, then it might not be value added for you.

 

[Mandy0528]

They're 2 different programs and not necessarily mutually exclusive. If you are already interacting with the FDA to execute an EFS, what different interactions would you be expecting from TAP? What are you intending to learn or get out of participating in either program? Note that the TAP acceptance criteria states that a TAP applicant will NOT have already submitted a presub after the breakthrough designation, so you may not even be able to apply at this point.

Note that TAP is a voluntary pilot program that FDA is running in order to solicit feedback. So, it may or may not be beneficial to you - if you anticipate having a lot of questions that you really want FDA input on, then the TAP program might be helpful, but if you already have a strategy in place and you already have interactions via q-sub, EFS, etc, then it might not be value added for you.

Thanks for your reply and analysis! Yes, we have compared the Pre-sub with TAP program. And there is another way for us (info from the FDA staff), we can change from Pre-sub (which is following the Breakthrough Q-number) to TAP. Once we confirm to change, maybe we can only use TAP instead of Pre-sub to consult FDA. So we have to consider the pros and cons of choosing TAP instead of Pre-sub, which is the most perplexing thing. By the way, our first Pre-sub meeting haven't started yet, so maybe that's why we can change.