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

PMA Review Costs Pooled In Unit-Cost Analysis; CDRH To Monitor Modules

This article was originally published in The Gray Sheet

Executive Summary

FDA's cost study of its device review resources likely will consolidate labor data for traditional, modular, expedited and panel-track PMAs into one cohort, rather than track each application type separately
Advertisement

Related Content

Regulatory News In Brief
Regulatory News In Brief
Device User-Fee Payment Made User-Friendly: Electronic Tracking Simplified
Device User-Fee Payment Made User-Friendly: Electronic Tracking Simplified
Second Year MDUFMA Stats Show Catch-Up Required To Achieve Cycle Goals
Second Year MDUFMA Stats Show Catch-Up Required To Achieve Cycle Goals
Girding For MDUFMA II: Premarket Review Unit Cost Study In Planning Phase
Advertisement
UsernamePublicRestriction

Register

MT021576

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