A new final rule from the Food and Drug Administration requires medical device manufacturers and importers to electronically submit reports of adverse events with devices to the agency.
Mandatory electronic reporting will improve the agencys process for collecting and analyzing postmarket medical device adverse event information, according to the rule available here. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA.
Medical device users can continue to submit written reports because of the relatively low volume of reports that FDA receives from the facilities. The rule also makes changes to the formats and content of medical device reports to reflect reprocessor information being collected on Form FDA 3500A.
The final rule is many years in the making, as FDA issued a proposed rule in August of 2009. Under the final rule, which is effective Aug. 14, 2015, a manufacturer or importer must obtain an exemption to continue to submit written reports, using existing FDA guidance for requesting exemptions. A year before the proposed rule for mandatory electronic reporting was published, FDA permitted manufacturers to start such reporting on a voluntary basis with few takers.
The final rule will reduce burdens on the FDA. When manufacturers and importers submit data elements to FDA in a paper format, the information must be manually entered into our internal electronic database before it can be effectively reviewed and analyzed, the final rule notes. Now, the manufacturers and importers will perform the data entry and FDA contends they will save the cost of submitting paper forms. FDA will get information available more quickly and reduce costs and transcription errors.
Adverse reports of death, serious injuries or malfunction must be reported within five, 10 or 30 days, depending on a number of factors. The final rule does not change underlying reporting requirements, just the manner of reporting. Text of the rule is available here and an accompanying Q&A document is here.
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