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

Proposed FDA Guidance Would Provide Alternate Route For 510(k) Applications

Executive Summary

US FDA has proposed new requirements for its abbreviated 510(k) program that could help certain sponsors get clearance for their products without having to compare to predicate devices.

You may also be interested in...



It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program

In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.

Proposed 510(k) Changes Elicit Some Industry Skepticism

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

FDA's Alternative 510(k) Proposal Falls Flat With Industry

The US regulatory agency has touted its newly proposed voluntary "expanded abbreviated" 510(k) program as a modern approach to regulation that will simplify the path for many. But industry groups are mostly scratching their heads.

Related Content

Topics

UsernamePublicRestriction

Register

LL1132098

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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