CFR 21-803.17-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.17:What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:
CFR 21-803.17-2014 history
2014CFR 21-803.17-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.17:What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?