USA Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for the USA.
| 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 |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | FDA Guidance Documents | English |
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