USA Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for the USA.

LOG INTO RAMS

 

Major Regulations
Document Number Published Language
Log in De Novo Classification Process - Evaluation of Automatic Class III Designation English
Log in Global Unique Identification Database (GUDID) English
Log in Modifications to Devices Subject to Premarket Approval (PMA) English
Log in 21 CFR 800-898 Medical Devices English
Log in Food and Drug Administration Safety and Innovation Act (FDASIA) English
Log in Food and Drug Administration Modernization Act of 1997 (FDAMA) 1997 English
Log in Food, Drug and Cosmetic Act English
General Guidance Documents
Document Number Published Language
Log in FDA Guidance Documents English