Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Emergency Guidance Clears Way For COVID-19 Blood Clot Detection Devices

Executive Summary

The US FDA is waiving premarket notification requirements for coagulation systems to monitor COVID-19 patients who are at high risk for blood clotting.

You may also be interested in...



FDA Updates Labeling Requirement In Emergency Blood Clot Detection Device Guidance

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.

FDA Suspends Premarket Notification Requirement For 7 Devices; 84 More Under Consideration

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.

Topics

UsernamePublicRestriction

Register

LL1131867

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel