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

Real time review of premarket approval (PMA) supplements succeeds:

This article was originally published in Clinica

Executive Summary

By the end of March, medical device companies in the US should have been notified that the six divisions of the Office of Device Evaluation will conduct a "real time" review of those supplemental PMAs which do not constitute a high risk. During a pilot study, assessment of the submissions took fewer than five days for the 24 cases that the CDRH accepted for real time review, said Susan Alpert, head of the ODE.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT084563

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