CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 803—MEDICAL DEVICE REPORTING > SUBPART A—General Provisions (§803.1 to §803.19) > 803.14—How do I submit a report electronically?

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.