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

In Brief: PMA summary availability

This article was originally published in The Gray Sheet

Executive Summary

PMA summary availability: FDA proposes posting approvals, denials and summaries of safety and effectiveness data for premarket approval applications on its Internet home page and discontinuing their publication in the Federal Register. FDA explains that the proposal, published in the June 27 Federal Register, "would expedite public notification of these actions" and make the information more accessible. FDA is also proposing to publish quarterly lists of PMA approvals and denials in the Federal Register. Comments on the proposed rule are due by Sept. 25...
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT008334

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