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

US FDA Exempts 200 Device Types From Premarket Notification

Executive Summary

The US FDA has finalized regulations exempting hundreds of class I and class II medical devices from premarket notification requirements.

You may also be interested in...



US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications

In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.

Petition Argues FDA Has Overstepped In PGx Regulation

A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness  an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.

Essure Update: Almost All Unsold Units Back To Bayer; Postmarket Study Enrollment Complete

The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.

Topics

UsernamePublicRestriction

Register

MT126062

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