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
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.
Technical 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).
Who is protected: Surgical patients and providers using robotically-assisted devices
Who must comply: Manufacturers of robotically-assisted surgical and AI-enabled medical devices
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Status | In effect |
| Protection strength | Moderate protection |
| Effective date | 1976-05-28 |
| Enacted | 1976-05-28 |
| Citation | 21 U.S.C. § 360(k); 21 C.F.R. Part 807 |
| Enforced by | U.S. Food and Drug Administration (CDRH) |
| 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 |
| Last verified | 2026-06-17 |
| Official source | FDA Safety Communication: Robotically-Assisted Surgical Devices (FDA.gov) ↗ |
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