Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I have a client who has been invited to enroll in the TAP Pilot.  They meet the criteria for enrollment and have asked for advice on whether or not to apply.

This is a very new program (kicked off in January 2023).  Not much information from actual participants, as it is behind the confidentiality curtain with the Breakthrough Device Designation.

Can anybody offer some insight into actual experience in the program?

Thanks in advance!

Hi all,

I too am curious about the benefits of this program. I have read what is stated on the TAP FDA page, but can anyone provide real world insight? How is it more beneficial than what BDD or STeP already provides - is it just another marketing tool or do we (the industry) expect the shorter turnaround time metrics to actually be met by FDA?

Also, if anyone has information on why only two OHTs are eligible until more are added, that would be appreciated. Any additional context on the history of why this program was created would also help.

Thanks
Hiral

---------------------------------
Hiral Dutia
Manager, Regulatory Affairs
Third Pole Therapeutics
Waltham, MA
USA
---------------------------------



Original Message:
Sent: 07-Dec-2023
From: Anonymous Member
Subject: Total Product Lifecycle Advisory Program (TAP)

This message was posted by a user wishing to remain anonymous

I have a client who has been invited to enroll in the TAP Pilot.  They meet the criteria for enrollment and have asked for advice on whether or not to apply.

This is a very new program (kicked off in January 2023).  Not much information from actual participants, as it is behind the confidentiality curtain with the Breakthrough Device Designation.

Can anybody offer some insight into actual experience in the program?

Thanks in advance!

Hiral,

There are a good number of articles in the trade press (including RAPS/RF) which I won't link to, but if you search they'll provide further context.

For the formal details reference MDUFA V (effective FY 2023-27) discussions and in particular the commitment letter (TAP starts on p. 24).

Short answer: it's a way to get some level of concurrent review for insurance purposes and is focused on devices which already have Breakthrough or STeP Designation. Also, it's a pilot and is being rolled out slowly over time (hence limitation to specified OHTs and a certain number of submissions).

Hope that helps!

------------------------------
Jonathan Amaya-Hodges
Director, Technical Services
Suttons Creek, Inc.
United States
jamaya-hodges@suttonscreek.com
------------------------------

Original Message:
Sent: 12-Mar-2024 20:08
From: Hiral Dutia
Subject: Total Product Lifecycle Advisory Program (TAP)

Hi all,

I too am curious about the benefits of this program. I have read what is stated on the TAP FDA page, but can anyone provide real world insight? How is it more beneficial than what BDD or STeP already provides - is it just another marketing tool or do we (the industry) expect the shorter turnaround time metrics to actually be met by FDA?

Also, if anyone has information on why only two OHTs are eligible until more are added, that would be appreciated. Any additional context on the history of why this program was created would also help.

Thanks
Hiral

---------------------------------
Hiral Dutia
Manager, Regulatory Affairs
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 07-Dec-2023
From: Anonymous Member
Subject: Total Product Lifecycle Advisory Program (TAP)

This message was posted by a user wishing to remain anonymous

I have a client who has been invited to enroll in the TAP Pilot.  They meet the criteria for enrollment and have asked for advice on whether or not to apply.

This is a very new program (kicked off in January 2023).  Not much information from actual participants, as it is behind the confidentiality curtain with the Breakthrough Device Designation.

Can anybody offer some insight into actual experience in the program?

Thanks in advance!