RoboBoom
Association for Advancing Automation (A3)· September 25, 2026· 13:26

Who Gets to Say Yes to a Robot? FCC, FDA and ISO Explained

Aaron Prather, director of market intelligence at the Association for Advancing Automation (A3), examines three kinds of permission shaping robotics: US market clearance, medical adoption, and interoperability.

In this talk

  1. 2:36

    FCC reviews overseas robots model by model

    Prather explains that new foreign-made advanced robots need FCC equipment authorization, with conditional approval available after a national security review. Husqvarna received clearance for four robotic mowers, and India-based Addverb received it for three autonomous mobile robots on September 18. Approval applies to specific models and may involve further review of supply chains, so buyers should check each robot’s status and conditions.

  2. 6:27

    FDA clearance starts the adoption process

    Neptune Medical’s Triton 1 endoscopy robot received FDA 510(k) clearance, which allows it to be marketed as substantially equivalent to an existing device. Its flexible scope can stiffen to support therapeutic procedures. In a 50-patient study, physicians completed the procedure in all cases; Neptune reported a 54.2% detection rate against a 35% benchmark, with no adverse events reported. Prather says clinical use and hospital purchasing will determine whether it gains traction.

  3. 9:21

    A standard aims to connect robot fleets

    Prather describes how robots from different vendors can struggle to coordinate in the same warehouse. ISO 21423 is designed to define communication protocols for industrial mobile robots and fleet managers, and it is ready for publication. InOrbit released Open Robots under the Apache 2.0 license, which the company says provides the first reference implementation of the standard. Shared protocols may reduce vendor lock-in, though integration work will remain.

  4. 12:26

    Three decisions shape whether robots get used

    Prather sums up the episode’s three gatekeepers: national security and supply-chain review, medical regulation and adoption, and standards for robots to communicate. Each affects a different step between a robot being available and becoming useful in a real operation.

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