Learn more about our Regulatory Affairs work.
AdvaMed®, the world’s largest trade organization representing medical technology companies, wrote a letter to U.S. Department of Commerce Secretary Gina Raimondo “to strongly encourage the implementation of policies that ensure…
A large group of Democratic lawmakers is requesting that the Biden administration enact a finalized federal rule that would give seniors on Medicare access to life-saving medical treatments.
Thought leaders across the country are urging the Administration to enact the Medicare Coverage of Innovative Technology (MCIT) rule that was set to go into effect March 15 before it…
A growing number of patient groups are expressing their support to the Centers for Medicare & Medicaid Services (CMS) of the Medicare Coverage of Innovative Technology (MCIT) rule.
MY01’s device helps diagnose acute compartment syndrome (ACS), a relatively common and potentially lethal muscle condition notably suffered by Tiger Woods in his car accident last February.
Creating a clear and consistent pathway to coverage for new and innovative medical technologies will ensure Medicare patients’ access to life-saving and life-enhancing care.
Last year, CMS proposed a new Medicare coverage pathway for breakthrough technologies called Medicare Coverage of Innovative Technology (MCIT). Via the this pathway, FDA-designated and approved breakthrough technologies, which are…
Proper servicing of complex, life-saving and life-sustaining medical devices is vital to their safe and effective functioning and the safety of patients and device users.
FDA’s postmarket regulations encompass every aspect of a device’s manufacture – from production and processing to packaging and distribution.
Every year, the FDA reviews thousands of devices to assure that they are safe, effective, and high-quality.