Elizabeth Orr
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Latest From Elizabeth Orr
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.
FDA Lets Some Changes To Monitoring Tools Bypass Clearance Process During COVID-19 Pandemic
Manufacturers can expand the remote-use capabilities of patient-monitoring devices like thermometers and stethoscopes without alerting the US FDA during the coronavirus crisis, a new guidance document from the agency says.
UK Court Blocks Edwards’ TAVR Device For Patent Infringement
Edwards’ Pascal transcatheter valve repair devices has been blocked from most use after being found to infringe on Abbott’s patents by a British court.