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

CDRH And Industry Scrutinize The Value Of User-Filed Medical Device Reports

This article was originally published in The Gray Sheet

Executive Summary

As CDRH reforms its postmarket surveillance systems, it will rely less on "passive" methods of surveillance, such as traditional user-initiated medical device reports (MDRs), and more on "active" systems, such as MedSun reporting and patient registries

You may also be interested in...



Canada Allows Exceptional Drug, Device Imports To Tackle COVID-19 Shortages

Medical products that do not fully comply with Canadian requirements but are manufactured according to comparable standards are being allowed into the country to deal with COVID-19-related shortages.

RECOVERY Coronavirus Study ‘Will Attract Global Players To UK’

A randomized COVID-19 study spanning the whole of the UK could help to bolster the UK’s reputation as a location for future clinical trials. It is also being seen partly as the result of the UK regulator's "decisive action" in fast-tracking trials for potential COVID-19 therapies.

Warning Letter Roundup & Recap – 8 April 2020

Manufacturers of endoscopic equipment, biofeedback devices and thermometers were among those cited for regulatory violations in US FDA warning letters this week. A total of four device-related enforcement missives were released by the agency.

UsernamePublicRestriction

Register

MT023435

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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