Center Archives - Medical Design Sourcing

The Advanced Medical Technology Association (AdvaMed) is asking the Centers for Medicare & Medicaid Services (CMS) to move fast on a new way to guarantee reimbursement for new medtech innovations.

CMS repealed the Medicare Coverage of Innovative Technology (MCIT) program last year but promised to explore other options to improve the coverage process for access to innovative and beneficial medical devices.

Now, a pathway called the Transitional Coverage for Emerging Technologies (TCET) program could take its place. CMS and medtech industry representatives have discussed the need for Medicare coverage reforms in two listening sessions (transcripts with webinar replay information are here and here).

In an Aug. 1 letter to CMS Administrator Chiquita Brooks-LaSure and Principal Deputy Administrator and COO Jon Blum, AdvaMed called on them to issue a proposed rule this year.

“We believe that CMS, in order to advance its health equity and other…

FDA medical device product recalls dropped last year to the lowest number since 2013, according to a Medical Design & Outsourcing analysis of newly released recall data from the regulatory agency.

Device products recalled in fiscal year 2021 (ended Sept. 30) totaled 2,607, a 14.3% drop from the 3,042 recalls reported in fiscal 2020.

The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols, according to FDA’s Center for Devices and Radiological Health (CDRH) annual report. CDRH Director Dr. Jeff Shuren said in September that the agency was “starting to turn the corner” on catching up on submissions, after having focused on the pandemic and issuing emergency use authorizations (EUA) in record times. But that was also before the virus’s omicron variant hit.

The 2,607 figure from last year is the fewest product recalls dating back to fisc…

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AdvaMed pushes CMS for proposed TCET pathway rule this year

MDO analysis: FDA medical device recalls drop to lowest levels since 2013