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.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
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.
Pre-Market
Every year, the FDA reviews thousands of devices to assure that they are safe, effective, and high-quality.
Technology & Regulatory Affairs
AdvaMed® advocates and works for a consistent, predictable, and transparent regulatory system.
Seniors Should Have Access to Breakthrough Medical Devices. Here’s Why
Unequal access to medical technologies and, more broadly, health care services continues to persist – often disproportionately impacting the lives of racial and ethnic minorities.
Industry 4.0 and Medical Devices
This white paper discusses the quality and regulatory approach for medical devices and software tools that contain AI/ML-based software.
CMS Policy Update Breathes New Life into Care Options for Medicare Beneficiaries
Unequal access to medical technologies and, more broadly, health care services continues to persist – often disproportionately impacting the lives of racial and ethnic minorities.
Optimizing CAPAs in the Medical Device Industry
This white paper explores how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”.