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Latest From Elizabeth Orr
Manufacturers of endoscopic equipment, biofeedback devices and thermometers were among those cited for regulatory violations in US FDA warning letters this week. A total of four device-related enforcement missives were released by the agency.
The US FDA released five device-related close-out letters in March.
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.
Pear Therapeutics’ Somryst insomnia treatment tool has become the first FDA-cleared product that was reviewed through the agency’s Software Precertification Pilot Program.
The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.
Companies offering OTC sample collection kits to help diagnose COVID-19 quickly fell under scrutiny in the US because the FDA hasn’t authorized any OTC tests.