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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Hits User-Fee-Era Record For 'Novel' Devices: A New Normal?

This article was originally published in The Gray Sheet

Executive Summary

Approvals of PMAs and panel-track supplements, as well as de novo devices, hit a 15-year high in calendar year 2015, according to a "Gray Sheet" analysis. FDA and industry experts respond to the data; also, check out our infographic of 2015 FDA approval trends, including a tally of the firms that captured the most PMAs and 510(k)s last year, and more.

Advertisement

Related Content

US Approvals Analysis: Cook Churns Out 510(k)s In Q3
Snapshot: US Pediatric Device Approvals Stay Steady, Despite Overall FDA Surge
US Approvals Analysis: FDA Delivers Strong Half-Year Volumes
US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals
US Approvals Analysis: Slow Month For PMAs, Better For 510(k)s
US Approvals Analysis: Strong Q3 For Metabolic-Disease Devices
FDA Taps New Office of Device Evaluation Director From Industry
2016 Original PMAs And Panel-Track Supplements
FDA MDUFA III Performance, By The Numbers
Successful De Novo Petitions Double With Advent Of Direct Route

Topics

Advertisement
UsernamePublicRestriction

Register

MT034883

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