Electronic Medical Device Reporting (eMDR)

FDA through draft guidance dated Aug 21, 2009 has tried to address general issues related to its proposed rule that require the submission of medical device reports in an electronic format which it can process, review, and archive. 21 CFR Part 803 specifies the specific requirements for the submission of the post-market medical device requirements. In this draft guidance FDA has tried to address some of the issues related to the electronic submission of the of post-market medical device reports and has also provided links for obtaining more detailed information on the preparation of an electronic MDR submission.

Please be aware: - This draft guidance does not apply to adverse event reports associated with devices subject to an approved investigational device exemption or reports submitted for post approval studies

The Guidance defines an electronic MDR submission as “a file containing one or more medical device reports in an electronic format that FDA can process, review, and archive”. An electronic MDR contains the same data elements as those specified in a 21 CFR 803 for a particular type of report. User facilities must include the information specified in 21 CFR 803.32. Importers must include the information specified in 21 CFR 803.42. Manufacturers must include the information specified in 21 CFR 803.52. MDRs should be configured according to the Health Level Seven Individual Case Safety Report (HL7 ICSR) message format so as to enable the FDA to process, review and archive them.

The guidance also provides information and the links to the additional information on the preparation of electronic medical device reports and their subsequent submission through the FDA ESG. Apart from this, the guidance has also provided solutions for some of the practical issues that one might encounter during the preparation and the submission of the electronic MDR. Guidance can be obtained at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm175805.htm

For more information on the update and to know how mdi can be useful in electronic MDR submission please email us at info@mdiconsultants.com and reference Electronic MDR.