| Regulatory Authority | Food and Drug Administration |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I,II,III |
| Medical Device Regulations | 21 CFR Part 820 | Click Here |
| IVD Classification | I,II,III |
| In Vitro Diagnostics Regulations | Overview of IVD Regulation |
| Registration Process | Device Registration and Listing | Click Here |
| Registration Timeline | For 510k it takes 90 days and for PMA it takes 180 days. |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in English Language |
| Database | Medical Device Database | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | Class I: Exempt or 510(k) Class II: 510(k), DeNovo Class III: PMA, DeNovo |