Medical Device Reporting: Electronic Submission Requirements

Dear Sir/Madam: Attached please find comments of the Medical Imaging & Technology Alliance (MITA), in response to the Proposed rule in the Federal Register, specifically 74 Federal Regiister 42203, Friday, August 21, 2009, Docket No. FDA-2008-N-0393, RIN 0910-AF86, to amend the FDA postmarket medical device reporting regulation 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 that FDA can process, review, and archive. Also attached for ease of reference is the draft Guidance and proposed rule with numbered lines to correspond to our comments. Sincerely, Richard M. Eaton, Industry Manager, Medical Imaging & Technology Alliance (MITA)