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From Health Law Daily, February 14, 2014

Adverse event reports must now be electronically submitted

By Anthony H. Nguyen, JD

Device manufacturers and importers must submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the FDA in an electronic format that the agency can process, review, and archive. In addition, the regulations will be revised to include mandatory electronic reporting to 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 the FDA. The final rule is effective August 14, 2015 (Final rule79 FR 8832, February 14, 2014).

Regulation. On August 21, 2009, the FDA published a proposed rule (74 FR 42203) to amend 21 CFR part 803 to require manufacturers, importers, and user facilities to submit MDRs to the FDA in an electronic format (the 2009 proposed rule). For over 20 years, the FDA has received postmarket MDRs in a paper format through the mail. In 2008, the FDA permitted manufacturers to submit postmarket MDRs electronically, on a voluntary basis. This final rule will now require the electronic submission to the FDA of manufacturer and importer MDRs.

The FDA stated that the rule is an important step toward improving its systems for collecting and analyzing postmarket MDRs, noting that the current process used by manufacturers and importers to submit data elements to the FDA in a paper format is manually entered into the internal electronic database before it can be effectively reviewed and analyzed. The FDA further stressed that the change would save the cost involved with submitting paper forms, as well as making information available more quickly to the agency.

The final rule changes to reporting includes reports of deaths, serious injuries, and malfunctions that must be submitted to the FDA in initial 5-day, 10-day, or 30-day individual MDRs as well as information that must be reported to the FDA in supplemental or follow-up reports. It does not change the underlying reporting requirements, only the manner in which they are submitted to the FDA.

Under the final rule, the FDA noted that it anticipated the following benefits: (1) reducing the industry’s time and costs associated with transcribing data from internal data management systems to paper and mailing the paper reports; (2) reducing the FDA’s transcription errors, time, and costs associated with receiving paper reports and transcribing data to electronic format for review and analysis; (3) expediting access to safety information in a format that supports efficient and comprehensive data analysis and reviews; and  (4) enhancing the FDA’s ability to rapidly communicate information about suspected problems to the medical device industry, health care providers, consumers, and other government agencies.

In order to address concerns that could arise from the MDR changes to an electronic submission, the FDA also issued a guidance titled “Questions and Answers About eMDR—Electronic Medical Device Reporting” to provide general information on preparing and sending an electronic postmarket medical device report to the FDA’s Center for Devices and Radiological Health.

Revisions to 2009 proposed rule. Because of concerns over the cost of implementation for user facilities, and the relatively low volume of reports the FDA receives from such facilities, the final rule does not require user facilities to adopt electronic reporting. The FDA noted that the benefits of the rule can be achieved without applying the electronic reporting requirement to user facilities. Although the agency encouraged user facilities to file reports electronically, the FDA will permit these user facilities to continue to use paper forms for reporting. Additionally, the rule modifies the existing regulation to list information for reprocessed single use devices, in order to reflect changes already made to the Form FDA 3500A, in accordance with Medical Device User Fee and Modernization Act of 2002 (P.L. 107–250).

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