FDA Finalizes Electronic Medical Device Reporting Rule – 14 February 2014

Posted on February 17, 2014. Filed under: Health Technology Assessment, Patient Safety |

FDA Finalizes Electronic Medical Device Reporting Rule – 14 February 2014

“A final rule promulgated by the US Food and Drug Administration (FDA) will require medical device manufacturers and importers to submit adverse event reports to the agency through a specific electronic format.

While FDA has long required manufacturers to report adverse events to it under 21 CFR 803, the medical device reporting (MDR) regulation, those reports have been submitted in paper form through Form FDA-3500A.

But as with many forms submitted to FDA, the agency is moving toward an electronic submission standard, arguing that digital submission is faster, cheaper, more accurate and allows for better analysis and reporting.”

… continues on the site

Medical Device Reporting: Electronic Submission Requirements AGENCY: Food and Drug Administration, HHS – 14 February 2014

“Action: Final rule.
Summary: The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to 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 will improve the Agency’s process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information
collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
DATES: This final rule is effective August 14, 2015”

… continues on the site

Questions and Answers about eMDR – Electronic Medical Device Reporting – Guidance for Industry, User Facilities and FDA Staff – 13 February 2014


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