CMS Promises Actions To Support TCET Pathway
CMS has released a list of actions and guidance documents it plans to take to support the TCET pathway.
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Comments submitted by industry members about CMS’s TCET notice highlight the need for greater device eligibility and transparency for the pathway.
While many industry groups have praised the introduction of TCET, a replacement for the repealed MCIT rule, a Washington Analysis expert has his doubts.
New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears
With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers. Medtech Insight’s round-up of four device-specific documents is below.