FDA 510(k) — surgical robots
FDA Premarket Notification (510(k)) Pathway for Robotically-Assisted Surgical Devices
United States · 21 U.S.C. § 360(k); 21 C.F.R. Part 807
- Status
- In effect
- Took effect
- May 28, 1976
- Applies to
- Manufacturers of robotically-assisted surgical and AI-enabled medical devices
- Enforced by
- U.S. Food and Drug Administration (CDRH)
Robotically-assisted surgical devices (RASD) — like Intuitive's da Vinci or Stryker's Mako — are FDA-regulated medical devices. Most clear the market through the 510(k) pathway by showing substantial equivalence to a predicate device. The FDA issued a 2019 safety communication and continues to police off-label robotic mastectomy and AI-software updates under its evolving 'Predetermined Change Control Plan' authority.
Who is protected: Surgical patients and providers using robotically-assisted devices
Legal detail
21 U.S.C. § 360(k); 21 C.F.R. § 807 subpart E. RASD product codes NAY (Class II). FDA Feb. 28, 2019 safety communication on robotic mastectomy; FDA AI/ML PCCP guidance finalized Dec. 2024 under FDORA § 3308 (21 U.S.C. § 360e-4).
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Strength | Moderate |
| Enacted | May 28, 1976 |
| Citation | 21 U.S.C. § 360(k); 21 C.F.R. Part 807 |
| Private right of action | No, agency enforcement only |
| Penalties | Warning letters; civil monetary penalties; injunction; criminal prosecution under FDCA |
| Topics | healthcare AI · consumer protection · automated decision-making |
| Agency page | FDA Safety Communication: Robotically-Assisted Surgical Devices (FDA.gov) |
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