The Problems State Right-to-Repair Statutes Pose for Patients and Hospitals
The long-term implications of state right-to-repair laws could have devastating consequences for health care providers and their patients.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed Encourages Administration to Consider Patient Needs as It Addresses Semiconductor Shortage
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…
38 House Democrats Join Call to Give Seniors Access to Life-Saving Medical Care
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.
ICYMI: Medical Experts, Lawmakers, and Innovation Funders Urge Administration to Grant Medicare Beneficiaries Expanded Coverage of FDA-Designated “Breakthrough” Technologies Through MCIT Rule
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…
Patient Groups Support Giving Seniors Access to Life-Saving Medical Technologies Through MCIT
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 Inc. Receives FDA Clearance for the MY01 Continuous Compartment Pressure Monitor as an Aid in Diagnosis of Compartment Syndrome
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.
Transitional Coverage of Emerging Technologies (TCET)
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.
Give Innovative Medtech and Patients a Future with MCIT
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…
The “Right to Repair” is Wrong for Patients
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.
Post-Market
FDA’s postmarket regulations encompass every aspect of a device’s manufacture – from production and processing to packaging and distribution.