FDA To Endoscope Makers: Remove Steris Sterilizing System From Labeling
Endoscope makers who currently instruct users to clean the devices with Steris' System 1 liquid chemical sterilization system may have to file for additional FDA approval or clearance after relabeling their products to reflect an alternative reprocessing method, the agency says
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A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
CMS is proposing to classify all CGMs and insulin pumps as “items requiring frequent and substantial servicing” to expand device choice and access for Medicare beneficiaries. Under this framework, CMS also intends to move Class II devices, which include CGMs from Abbott and Dexcom and pumps from Tan
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.