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The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.

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Electronic Code of Federal Regulations

e-CFR Data is current as of September 29, 2014

Title 21Chapter ISubchapter HPart 803Subpart A → §803.14


Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart A—General Provisions


§803.14   How do I submit a report electronically?

(a) You may electronically submit any report required by this part if you have our prior written consent. We may revoke this consent at anytime. Electronic report submissions include alternative reporting media (magnetic tape, disc, etc.) and computer-to-computer communication.

(b) If your electronic report meets electronic reporting standards, guidance documents, or other MDR reporting procedures that we have developed, you may submit the report electronically without receiving our prior written consent.



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