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

510(k) Modifications Guidance Shows FDA Focus On Least- Burdensome Principle, Routine Risk Tests

Executive Summary

A final 510(k) modifications guidance released from US FDA contains at least nine changes in emphasis from an August 2016 proposal. It enunciates the agency's plan to abide by "the least burdensome principle" in evaluating sponsors submissions for changes, and it recommends that any decision by a company not to submit a new 510(k) after a device alteration be routinely verified and validated.

You may also be interested in...



US FDA Updates Policy For Adding Cleared Assays To Additional Instruments

Under a draft guidance, IVD manufacturers wouldn’t need to submit a new 510(k) if they were clearing an assay for use with an instrument similar to those it was already cleared on.

Despite 510(k) Software Guidance, US FDA's Hands May Still Be Tied

While a recent final guidance when a 510(k) is needed for software changes is helpful, a key industry lobbyist says it doesn't do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight.

510(k) Modifications Guidance Docs Finalized At Long Last

After years of controversy, US FDA finally succeeded in updating its 20-year-old guideline on when a new 510(k) is needed for device modifications. Split out as its own document is a guideline targeting the issue specifically for software modifications.

Related Content

Topics

UsernamePublicRestriction

Register

MT121680

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