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Latest From Elizabeth Orr
FDA Wants To Put Hep C Tests On 510(k) Pathway
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.
FDA OK’s Insomnia Treatment Through Software Pre-Cert Program
Pear Therapeutics’ Somryst insomnia treatment tool has become the first FDA-cleared product that was reviewed through the agency’s Software Precertification Pilot Program.
COVID-19 Leads FDA To Relax Rules On Surgical Masks, Offer EUAs For Reprocessing Some Respirators
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.
When Chasing COVID-19 Market Opportunities, Watch For Regulatory Hurdles
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.
COVID-19: FDA Device Center Chops In-Person Meetings, Lengthens Submission Deadlines
The US agency’s device center has offered an extension on some submission deadlines and announced a transition to teleconferences from in-person meetings during the COVID-19 pandemic.
Cepheid Nabs First FDA Authorization For Rapid-Response COVID-19 Test
A rapid-response test from Danaher business unit Cepheid will be the first quick COVID-19 diagnostic to reach the US market, the US FDA announced on 21 March.