Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA No Longer Publishing Quarterly PMA And HDE Decisions

Executive Summary

The US FDA has stopped publishing its list of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register on a quarterly basis. The agency says the change will save money and resources.

You may also be interested in...



FDA Proposes End To Quarterly Reporting On HDE, PMA Decisions

A proposal from the US FDA would end quarterly publication of PMA and Humanitarian Device Exemption verdicts in the Federal Register. The agency says the practice is inefficient and duplicates online publication.

Class I Recall For GE Healthcare CARESCAPE Ventilator

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

Novel VR Treatment For Mental Illness Gets FDA Breakthrough

The US FDA has granted its breakthrough designation to a virtual reality therapy that recreates everyday scenarios for patients dealing with severe anxiety and schizophrenia.

Topics

Latest News
UsernamePublicRestriction

Register

MT144952

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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