OBSERVATORY / REGULATION
FDA Oversight of Computer-Assisted Surgical Systems
Computer-assisted surgical systems are medical devices whose permitted uses depend on FDA authorization, labeling and applicable controls. The FDA page also explains that these systems do not perform surgery without direct human control.
Rule snapshot
| Jurisdiction | United States |
|---|---|
| Regulator | U.S. Food and Drug Administration |
| Topic | medical robotics |
| Effective date | Date not published |
| Current status | Current |
Published requirements
- use within cleared or approved indications
- follow labeling and training requirements
- report device problems through applicable channels
Check the regulator before acting.
This educational summary is not legal or operational authorization. Rules, waivers and local restrictions can change.