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

Public MedSun Web Site Gives Information On Device Problems

This article was originally published in The Silver Sheet

Executive Summary

A NEW ALL-ACCESS MEDSUN WEB SITE goes live Nov. 16 to educate health care providers about device-related problems observed by hospitals in FDA's MedSun adverse event reporting network. Although the aim is to improve patient safety, the Web site may also help enhance communication between hospitals and manufacturers, says FDA MedSun Project Officer Marilyn Flack. She believes companies also will be interested in the information on the Web site because it will “give them an eye into the mind of FDA that month - things we thought were important that we're talking to the sites about.” Meanwhile, the agency is making headway on its postmarket transformation initiative, including planned changes to the MAUDE adverse event database and progress on risk communication issues.

You may also be interested in...



QUOTED. 6 April 2020. Bethany Hills.

Diagnostics company Bodysphere had to retract an announcement that it had received an emergency use authorization from the US FDA for a COVID-19 serologic test. See why Bethany Hills, an attorney with law firm Morrison & Foerster, says this may be a cautionary tale for other manufacturers.

Health And Wellness Trademark Review 31 March, 2020

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Faster, Better? Fujitsu, Polarisqb 'Quantum-Inspired' Tech Speeds Discovery

Japanese ICT giant applies novel advanced computing techniques with a US venture partner to more rapidly identify lead molecules from a huge virtual space.

Topics

UsernamePublicRestriction

Register

MT036164

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