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# MDR Violations Led CDRH Warning Letters
- URL: https://www.fdaweb.com/mdr-violations-led-cdrh-warning-letters/
- Published: 2017-01-17T12:00:00.000Z
- Updated: 2026-09-14T22:00:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137729

The CDRH Office of Compliance issued 17 Warning Letters in 2016, with 16 of them relating to Medical Device Reporting (MDR) violations. *Inside Medical Devices*, published online by Covington & Burling, [says](https://www.insidemedicaldevices.com/2017/01/2016-year-in-review-mdr-reporting-enforcement/?ref=fdaweb.com) that seven letters determined that the company did not have written MDR procedures that satisfied regulatory requirements, while nine others identified deficiencies in the manufacturer’s written procedures for MDR reporting.

The post lists some of the major deficiencies that the agency cited and recommends that manufacturers review their written procedures for MDR reporting and the agency’s recommendations in a final [guidance](https://www.fdaweb.com/fda-guide-on-mdr-reporting/) on the subject issued 11/8/16.