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

FDA Unveils Proposal For Streamlined De Novo Reviews

This article was originally published in The Gray Sheet

Executive Summary

Despite statutory constraints, FDA is hoping to trim as many as 90 days off the total review process for de novo petitions.

You may also be interested in...



Successful De Novo Petitions Double With Advent Of Direct Route

FDA granted more than double the number of de novo petitions in FY 2013 compared to past years, reflecting the availability of the direct de novo pathway recently established by Congress. De novo petitions allow a device that FDA deems to be low-to-moderate risk but without a clear predicate to enter the market without requiring a PMA.

De Novo Draft Guidance: FDA Review With No 510(k) Submission

FDA releases an update of its draft de novo classification guidance Aug. 14 to comport with FDA Safety and Innovation Act, and permit manufacturers to submit de novo applications for review without a preceding 510(k) submission.

De Novo Guidance Doesn’t Cut Review Time Enough, Industry Says

Industry is skeptical of FDA claims that the plan mapped out in a recent draft guidance on de novo petitions will speed the review process for devices that aren’t a good fit for either the 510(k) or PMA programs.

Related Content

Topics

UsernamePublicRestriction

Register

MT030610

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