USA Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for the USA.
Related services:
- Consulting & Training for Medical Device Unique Device Identification (UDI) Requirements
- FDA 510(k) Submission Consulting and Approval
- FDA eMDR Adverse Event Reporting for Medical Device Companies
- FDA QSR Consulting
- FDA Submission for Medical Devices and In Vitro Diagnostics (IVDs)
- FDA US Agent Medical Devices in USA
- FDA認証（許可）取得のためのFDA 510(k)申請
- Human Factors Engineering (HFE) and Usability Testing for Medical Devices
- US FDA Consulting for Medical Device and IVD Manufacturers
- US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
- US FDA Medical Device Classification System
- US FDA Medical Device Establishment Registration
- US FDA Official Correspondent for Medical Device Companies
- US FDA Pre-Sub (Q-Sub) Consulting for Medical Devices
| 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 |
