The FDA has initiated the process to amend its postmarket medical device reporting regulation (21 CFR Part 803) to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format.
The Agency currently processed and analyses approximately 100,000 initial individual MDRs on a paper FDA Form 3500A. According to FDA figures, shifting to mandatory eMDR would improve it’s process for collecting and analyzing postmarket medical device adverse event information.
The proposed regulatory changes would also provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues. To support this, the proposed amendment to Part 803 includes modifications to the content of Form 3500A to better track information already required by FDA.
The implementation of the eMDR requirement is expected to reduce FDA annual operating costs by $1.25 million and generate industry savings of about $3.2 million.
The FDA has also issued a draft guidance document to assist industry and provide recommendations the preparation and submission of eMDRs in a manner that satisfies the requirements of the proposed regulation.
On January 26, 2010, Sparta Systems will be hosting a Seminar on eMDR at the Chicago Marriott O’Hare, in Chicago IL.
This seminar will address how medical device manufacturers can plan and prepare for a successful transition to electronic adverse event reporting. It will provide an overview and status report of the FDA’s Center for Devices and Radiological Health (CDRH) guidance, explore eMDR best practices and a successful eMDR implementation case study.
During the seminar, Axendia will provide an overview and status update on key initiatives driving FDA’s shift to eMDR. The discussion will cover background of the regulation and FDA guidance for eMDR implementation.
Ortho Clinical Diagnostics will discuss the challenges their company faced when planning for and designing transition to eMDR. They will then discuss best practices and lessons learned based on his successful eMDR implementation.
To learn more about this eMDR seminar and for registration information visit: http://www.spartasystems.com/media-center/seminars/preparing-for-emdr/