2011年 10月 7日
A parallel review pilot program newly deployed by the US FDA and the Centers for Medicare & Medicaid Services (CMS) could expedite the review process for some cutting-edge devices and make Medicare reimbursement requirements more transparent.
The program allows concurrent review of devices by both FDA and CMS staff, minimizing the time between FDA 510(k) clearance or approval and Medicare coverage decisions. Although FDA and Medicare reviews of medical devices are not identical, both agencies use clinical data to inform their decisions.
Devices qualifying for parallel review include:
The program is slated to last for up to two years, but will accept only three to five submissions per year. Assuming the program’s pilot phase proves successful, the agencies should seriously consider expanding access to the program to a wider variety of medical devices.