In February 2014, the U.S. Food and Drug Administration (FDA) published a final rule requiring medical device manufacturers and importers to submit mandatory initial and supplemental adverse event reports in electronic format. Companies have until August 14, 2015 to comply.
Companies must obtain a Web Trade Account from FDA’s Electronic Submission Gateway. FDA urges users not to wait until August 14 to create an account, as the process has many steps, including submitting a letter of non-repudiation to FDA and submitting a test electronic medical device report (eMDR). Voluntary electronic reporting has been available since 2008, so companies may begin creating accounts and reporting electronically now.
Once a company has an account, eMDRs can be submitted through FDA’s eSubmitter, which allows submission of one report at a time, or through Health Level 7 (HL7), which allows multiple reports to be submitted at once.
When are eMDR reports required to be submitted?
Device manufacturers and importers are required to submit eMDRs to FDA when evidence suggests a device may have contributed to a patient death or serious injury, or when a device malfunctions and reoccurrence of the malfunction would likely contribute to death or serious injury.
What other requirements does the final rule establish?
The final eMDR rule requires companies to keep copies of all adverse event reports, both paper and electronic, submitted to FDA and all acknowledgements received from FDA.
Registrar Corp helps medical device companies comply with U.S. FDA regulations. We can register a company with FDA, list a company’s devices, review device labels, assist with UDI requirements, and more. For questions about FDA’s eMDR rule or for assistance with FDA device regulations, contact Registrar Corp at +1-757-224-0177. Live help is available 24 hours a day at www.registrarcorp.com/livehelp.