Emergency Guidance Clears Way For COVID-19 Blood Clot Detection Devices
The US FDA is waiving premarket notification requirements for coagulation systems to monitor COVID-19 patients who are at high risk for blood clotting.
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The US agency added a minor update to the original guidance that broadens the labeling requirement for the devices to state they are only to be used as adjunctive diagnostics when evaluating a COVID-19 patient for risk of blood clots.
The US HHS and the FDA on 14 January published a notice that permanently waives premarket notification requirements for seven types of gloves that were given temporary waiver during the pandemic. Regulators are looking to expand the waiver to 84 other products.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.