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


Industry Urges FDA To Distinguish Between 510(k) Modification Factors

Executive Summary

Industry groups and companies said US FDA's August draft guidance is inappropriately intermixing two different standards for determining when a new 510(k) needs to be submitted for a device modification. Respondents to the draft guidance on 510(k) modifications are also looking for more clarity on FDA's expectations for companies to assess how cumulative changes to a device might trigger the need for a new submission. But overall, firms support the current draft more than the agency's abandoned 2011 attempt to revise its policy.


Related Content

510(k) Modifications Guidance Docs Finalized At Long Last
US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications
21st Century Cures Implementation: Device Provision Updates
21st Century Cures: Device Provisions
21st Century Cures: Device Provisions
House Set To Vote On Cures Nov. 30; Latest Version Includes 510(k)s In Breakthrough Pathway
Republican Congress, Trump Policies May Seek To 'Undo' FDA Device Safety Guidances; LDT Plan First To Go
FDA Calls For Full Risk Reviews For Device Changes In 510(k) Modifications Draft
A “Disastrous” Draft? Device Firms Take Issue With 510(k) Modifications Guidance





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