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


FDA data "insufficient for review cost assessment"

This article was originally published in Clinica

Executive Summary

The FDA's report on how much it costs the agency to conduct a product review will not provide the level of detail industry initially wanted. Dr Dale Geiger, the independent contractor conducting the study, told industry last week that the agency's labour reporting system is a truly "blunt tool". It does not differentiate between various types of premarket approval (PMA) applications, whether they be original, product development protocols, modular, expedited or panel-track supplements of Human Device Exemptions.





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