FDA Issues Final Rule Requiring Electronic MDR Reporting


On February 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) issued a final rule titled Medical Device Reporting: Electronic Submission Requirements that will require medical device manufacturers and importers to submit medical device reports (MDRs) electronically, beginning on or before August 14, 2015. User facilities will have the option to use traditional paper or electronic submission methods. Electronic MDRs (eMDRs) will be submitted to FDA’s existing Electronic Submissions Gateway (ESG) through either of two options: (1) FDA’s eSubmitter program or (2) Health Level Seven Individual Case Safety Reporting (HL7 ICSR) format. 

At the same time that it released the final rule, the Agency also released a final guidance document regarding the new eMDR requirement, titled Questions and Answers About eMDR – Electronic Medical Device Reporting.  The rule and guidance finalize draft versions of each that were issued on August 21, 2009.  The final rule is largely unchanged from the draft rule, with the main substantive difference being that FDA has extended the delay before the effective date of the rule to eighteen months, increased from the one year period proposed in the draft rule.

Reporter, Jessica Ringel, Washington, D.C., +1 202 626 9259, jringel@kslaw.com.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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