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


FDA Tries To Get 'Smart' In Standardizing 510(k) Reviews

This article was originally published in The Gray Sheet

Executive Summary

The agency's device center is in the midst of adopting a "Smart" 510(k) template to improve reviewer-to-reviewer consistency and speed up the learning curve for new reviewers. It is part of a broader IT push at the center to further standardize industry submissions and how they are reviewed, the Office of Device Evaluation's Barbara Zimmerman tells "The Gray Sheet."


Related Content

Government Watchdog Recommends FDA Improve Cybersecurity Reviews
'Quik' Review Program Builds On US FDA eSubmission Efforts
User-Fee Facts: 10 Key Medtech Details From US FDA Agreements
Industry, FDA Outline Costs Of New MDUFA Proposals; Quality Management A Strong Focus
FDA, Industry Agree On Working Groups To Support User-Fee Negotiations
Top 15 In '15: The Most-Read "Gray Sheet" Stories Of The Year
In Case You Missed It: Top 10 "Gray Sheet" Stories In November
FDA MDUFA III Performance, By The Numbers
Calls For More FDA Training In Lead Up To User-Fee Negotiations
TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot





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