Question Arising: FDA and "Parallel Review"

 A question arose today about FDA and Parallel Review (for NCDs, and with Medicare).

FDA has a webpage for multiple payor communications programs:

https://www.fda.gov/about-fda/cdrh-innovation/medical-device-coverage-initiatives-connecting-payors-payor-communication-task-force

https://www.fda.gov/about-fda/cdrh-innovation/medical-device-coverage-initiatives-connecting-payors-payor-communication-task-force#cms

Parallel Review 

Q: How many requests have been received for Parallel Review?
A: As of June 2024, there have been 97 formal requests to participate in Parallel Review.

Q: How many devices have completed Parallel Review?
A: Two devices have completed Parallel Review: Exact Sciences’ Cologuard in 2014External Link Disclaimer, and Foundation Medicine’s FoundationOne CDx in 2017.

Q: How much time did the companies save by using Parallel Review?
A: It is estimated that the NCD process typically takes 6-9 months. Cologuard received its FDA approval and the proposed NCD opened on August 11, 2014. The NCD was finalized on October 9, 2014, just under 2 months after the proposed NCD opened. FoundationOne CDx received its FDA approval and the proposed NCD opened on November 30, 2017. The NCD was finalized on March 18, 2018, about 3.5 months after the proposed NCD opened.