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


FDA Awash In Adverse Events: All-Time High Of 1.5 Million MDRs Reported In 2017

Executive Summary

US FDA statistics shared with Medtech Insight show that the number of Medical Device Reports sent to the agency dramatically rose last year, both in individual and summary formats. Might the agency's upcoming Voluntary Malfunction Summary Reporting Program slow the overall number of MDRs this year?


Related Content

FDA Asks For More Summary Adverse Event Reports Under Proposed MDR Program
Adverse Events Dip Slightly In 2016; MDR Summary Reporting To US FDA Ticks Up





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