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

Animal Planet: FDA Opens Adverse Event Files For Devices Used On Animals

Executive Summary

With the agency’s transparency under siege, US FDA is moving to put more adverse event data into public databases. First up: Thirty years of records on medical devices used in animals. The release could have ramifications for device-makers because some equipment, such as radiological devices, is used on both animals and humans.

You may also be interested in...



FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.

FDA Asks For More Summary Adverse Event Reports Under Proposed MDR Program

The US agency has proposed a Voluntary Malfunction Summary Reporting Program that will allow makers of an array of devices to submit Medical Device Reports in a summary, rather than individual, format to FDA. The program aims to make the MDR-reporting process more effective and give the agency clearer post-market visibility.

Class I Recall On Abbott Coronary Catheters

The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.

Topics

UsernamePublicRestriction

Register

MT124890

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