CMS, FDA Sign MOU, Paving the Route for Devices to Get to Market Faster

A new memorandum of understanding (MOU) between the FDA and Centers for Medicare & Medicaid Services (CMS) could eventually accelerate the regulatory route for PMA devices. The agreement, which was signed last week and will go into effect next month, will allow the FDA and CMS to share confidential information about a submission on a more regular basis. The MOU could lead to a dual-approval process for PMA devices between the agencies in which the FDA would make the safety and efficacy decision while CMS determines whether to reimburse for the device.
Devices & Diagnostics Letter