FDA, CMS planning parallel review

FDA and CMS are soliciting comments on plans to create a process for parallel review of medical products, which the agencies said would reduce the time between FDA approvals and CMS national coverage determinations. Specifically, the agencies are seeking input on how the review would be implemented, including the classes of products that would benefit from parallel review, the criteria used to grant parallel review and any barriers or disadvantages. The agencies intend to create a pilot program for parallel review of medical devices, which is expected to begin after the agencies have reviewed public comments. Comments are due by Dec. 16. ...