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

Breast Implant-Makers Now Required To File Individual Reports On Each Adverse Event, FDA Says

Executive Summary

The agency is redoubling efforts to warn women about the risks of silicone and saline breast implants after feedback from a recent advisory panel meeting. On 2 May, the regulator said it is requiring manufacturers to file individual Medical Device Reports for each adverse event regarding implants – part of a bigger effort to end its Alternative Summary Reporting Program for all devices.

Advertisement
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

MT125048

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