The Food and Drug Administration (FDA) is proposing to amend its 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.
- Mandatory electronic reporting would improve the agency’s process for collecting and analyzing postmarket medical device adverse event information.
- The proposed regulatory changes would 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.
FDA is also announcing a draft guidance document that provides recommendations on how to prepare and submit electronic MDRs to FDA in a manner that satisfies the requirements of this proposed regulation.
Date to Submit:
November 19, 2009. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 (the PRA) by September 21, 2009.
Addresses to Submit:
You may submit comments, identified by Docket No. FDA–2008–N–
0393 and/or RIN number 0910–AF86, by any of the following methods
Submit electronic comments in the following way:
• Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments
Submit written submissions in the following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA– 305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852
All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) (if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to http:// http://www.regulations.gov, including any personal information provided.
Also I have found some webinars which are related to MDR medical device reports which can be helpful
- Complaint Handling, MDR’s & Recalls
- Medical Device Complaints, MDR’s and Recalls
- Development and Audit of Complaint Handling and MDR Processes