In February 2014, the FDA submitted its final rule regarding updates to 21 CFR 803, Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities.  Up until now, manufactures and importers were able to submit a paper form, known as 3500A form, or an electronic equivalent.  Effective August 1 2015, electronic submissions will be the only acceptable format.  These submissions must be in HL7 format and sent to the FDA’s Electronic Submissions Gateway.  This will be a drastic change in the way MDR submissions occur for many organizations.  Luckily, the Administration has created a free desktop application that manufactures and importers can use to generate the HL7 files.  In addition, the FDA has created an API for organizations to use to turn their existing complaints management solutions into the HL7 format.  For more information, read on the FDA’s website here and here.

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