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


Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

MDR coding revamp: CDRH has a new 1Web site to help companies understand the new Medical Device Reporting (MDR) coding system that goes live July 1, marking the system's first redesign since its inception. FDA is addressing limitations of the current system, which has undefined or ambiguous codes, no formal process to request new codes and no hierarchical structure (2"The Gray Sheet" March 3, 2008, p. 9). Come July 1, the new codes can be used in Form 3500A mandatory adverse event reports, as well as any other device-related event reporting, such as clinical study and patient safety reporting. FDA anticipates it will stop accepting the old codes by April 2010

You may also be interested in...

Industry, Consumers Seek Greater Clarity In Hearing Aid Draft Guidance

Companies and consumer groups asked FDA for a clearer distinction between hearing aid devices and personal sound amplification products in recent comments submitted in response to an FDA draft guidance.

Regulatory Briefs: Draft Guidances On Hearing Aids, Syphilis Tests; Upcoming Panel Meetings

FDA issues draft guidance clarifying the difference between hearing aid devices and personal sound amplification products. Agency also issues draft guidance on the use of tests to screen human cells and tissues for syphilis. Boston Sci gets a new panel date for Watchman. More regulatory news.

Electronic medical device reporting update

Companies may begin using new FDA device problem codes in their mandatory adverse event reports beginning July 1, the agency says. The new electronic Medical Device Reporting (eMDR) coding 1system revamps the previous system with specific improvements to patient and device problem codes, the inclusion of component codes to clarify the part of the device associated with the adverse event, and improvements to code descriptions and definitions, FDA says. Old MDR codes will still be accepted, but only until April 2, 2010 (2"The Gray Sheet" April 6, 2009)

Related Content


Latest Headlines
See All



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