The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics.
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