Medtech Insight is part of the Business Intelligence Division 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


Government Watchdog Recommends FDA Improve Cybersecurity Reviews

Executive Summary

HHS OIG is recommending US FDA hold more pre-submission meetings, amend their Refuse-to-Accept checklist and update their "Smart" template for agency reviewers to improve oversight of medical device cybersecurity.


Related Content

Gaps Remain In US FDA's Response Procedures For Cybersecurity Events, OIG Says
Device-Makers Need To Open Up More On Cybersecurity In Pre-Market, Draft Guidance Says
US FDA Pushes Further On Cybersecurity Efforts Despite Limited Resources
New Safety Framework Mixes Current Efforts, New Investments At US FDA
FDA Tries To Get 'Smart' In Standardizing 510(k) Reviews
Identify and mitigate cybersecurity risks early on, US FDA tells device sponsors





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