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

FDA Cautions EUA-Holders They Have Same MDR Reporting Responsibilities As Other Manufacturers

Executive Summary

In further sign the agency is tightening oversight of EUA products, regulators have set up a Q&A web page for manufacturers explaining their responsibilities to report adverse events.

You may also be interested in...



FDA Issues New EUA Product Codes To Track Adverse Events, Imports

As the agency is starting to tighten EUA regulations, it says the new codes will help it better track adverse events and imports related to the products.

Georgia Device Sterilizer Sued For Allegedly Causing Cancer, Death

The lawsuit against Kendall Patient Recovery accuses the company of intentionally ignoring decades of data warning against risks posed by ethylene oxide, causing harm to communities around its facility.

Uncle Sam Is Searching For A Few Good Health IT Advisors

Experts representing manufacturers, patients, providers and federal agencies are being sought by the US government to advise the Office of National Coordinator for Health Information Technology on issues such as health IT standards and specifications.

Topics

UsernamePublicRestriction

Register

MT144229

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