JD Supra

A Break for Breakthrough Devices? CMS Issues Transitional Coverage for Emerging Technologies Notice

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies (TCET) pathway. 88 ...
JD Supra

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance ...
STAT

Medicare finalizes reimbursement rule for breakthrough medical devices

The Centers for Medicare and Medicaid Services has finalized its rule easing reimbursement for medical device makers. Called Transitional Coverage for Emerging Technologies, the program gives device ...
FierceBiotech

FDA outlines regulatory transition plan for COVID tests, devices as public health emergency wraps up

The FDA has laid down a path for the developers of COVID-19 tests and other pandemic-focused medical devices to finally make the transition to the foreseeable regulatory future, where the coronavirus ...
Healthcare Dive

FDA details plan to end emergency use authorizations

With the COVID-19 public health emergency set to expire on May 11, medical technology companies that brought devices to market under special pandemic rules will need to prepare transition plans soon, ...