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Also attached for ease of reference is the draft Guidance and proposed rule with numbered lines to correspond to our comments.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)
Attachments:
Medical Imaging & Technology Alliance (MITA) - Comment
Title: Medical Imaging & Technology Alliance (MITA) - Comment
View Attachment:
Medical Imaging & Technology Alliance (MITA) - Comment - 74FR42203
Medical Imaging & Technology Alliance (MITA) - Comment
This is comment on Proposed Rule
Medical Device Reporting: Electronic Submission Requirements
View Comment
Attachments:
Medical Imaging & Technology Alliance (MITA) - Comment
Title:
Medical Imaging & Technology Alliance (MITA) - Comment
Medical Imaging & Technology Alliance (MITA) - Comment - 74FR42203
Title:
Medical Imaging & Technology Alliance (MITA) - Comment - 74FR42203
Medical Imaging & Technology Alliance (MITA) - Comment - eMDR Draft Guidance
Title:
Medical Imaging & Technology Alliance (MITA) - Comment - eMDR Draft Guidance
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