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 Declines To Add 510(k)s To Pediatric Data Guidance, But Does Address De Novos

This article was originally published in The Gray Sheet

Executive Summary

Industry has asked FDA to expand the scope of its guidance on extrapolating adult trial data to pediatric submissions to include 510(k)s. In a final guidance, FDA declined to do so, but it did expand the scope of the guidelines to include de novo applications.

You may also be interested in...



Better Reimbursement, More Incentives Needed For Peds Device Development, Stakeholders Tell FDA

At a recent pediatric medical devices workshop at US FDA headquarters, the focus turned less to regulatory burdens and more to lacking reimbursement and financial incentives as barriers to bringing child-focused products to market.

US FDA Electromagnetic Compatibility Guidance Finalized

In the final medical device electromagnetic compatibility guidance FDA clarified the scope of applications that could use this guidance and added a recommendation for sponsors to identify and consider the intended use environmental that could affect the EMC of their products.

510(k)s Should Benefit From Adult-To-Peds Extrapolation Too, AdvaMed Says

The trade group says FDA's recent draft guidance on employing adult device data to help support a pediatric indication should be expanded to include 510(k)s, rather than being limited to PMAs and HDEs.

Related Content

Topics

UsernamePublicRestriction

Register

MT038347

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