The FDA and Centers for Medicare & Medicaid Services have launched a parallel review pilot program for medical devices. The pilot will allow for the streamlined, concurrent review of devices by both agencies and is only available for qualifying new technologies.
Device sponsors often focus solely on obtaining FDA approval, but find out later that Medicare coverage is not automatically forthcoming. But the parallel review can reduce time between FDA approval and Medicare national coverage determinations. The agencies have already issued procedures for voluntary participation and the guiding principles they will follow.
The program, which will last for up to two years with the possibility for extension, will focus on innovative technologies that can benefit from parallel review and will accept no more than three to 5 submissions annually, according to an FDA statement.
Currently, the trade group AdvaMed is reviewing the program specifics. "Overall, we support efforts to improve the timeliness, predictability and efficiency of FDA's regulatory decision-making process and CMS' coverage, coding and payment determinations[,]" Ann-Marie Lynch, executive VP of payment and health care delivery policy with AdvaMed, said in a statement emailed to DOTmed News. "However, we believe it is important to preserve the currently separate and distinct regulatory missions of FDA and CMS to ensure that each agency does not influence the functions and decisions of the other and to ensure the confidentiality of all proprietary information provided by manufacturers."
- see the FDA release
- check out the Federal Register notice
- read the DOTmed News story