Appealing An FDA Device Decision? Proposed Rule Clarifies Framework
US FDA has issued a proposed rule that explains what decisions are eligible for supervisory review, and sets a timeframe for filing appeals.
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A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.
The company ordered the recall after three stent fractures and a death occurred in an 89-participant clinical trial.
The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.