FDA has provided a tool that allows creation of a premarket submission eCopy that is meets FDA requirements. The guide for this tool is at the link provided.
FDA: Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices
Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803. Read more: https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices