The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s enforcement action against CardioMEMS for alleged clinical trial violations, medical device user fee agreement implementation, and AdvaMed’s priority list for the fiscal-cliff bill.
The US Food and Drug Administration (FDA) put its long-simmering concerns about CardioMEMS Inc.’s CHAMPION clinical trial into legal form with a warning letter recently, citing the firm for numerous regulatory violations.
The June 5 warning letter to CardioMEMS, which was made public on FDA's web site September 25, details alleged sponsor...
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
