The FDA’s prosthetic-arm order has two dates with different meanings. October 18, 2016, is the effective date of the published final order. May 9, 2014, is when the classification became applicable. The October document adds that earlier class II decision to federal regulations as section 890.3450; it does not announce a newly authorized arm. [2016-25001]

The category is narrower than all electronic prostheses. It covers prescription replacements for an absent upper limb that provide more than two independent, simultaneously powered degrees of freedom, including a powered elbow or shoulder. Their electrical controls are not implanted. Degrees of freedom describe independently powered movement, not a count of brain connections or proof of natural-arm function. [2016-25001]

A May 2014 VA report supplies a concrete example of the controls. It described shoe-mounted sensors translating foot movements into commands for the DEKA arm, with foot-controlled arm motion temporarily disabled during walking. Some users also employed electrodes detecting activity in remaining arm or shoulder muscles. VA explicitly distinguished those arrangements from direct brain control; that historical description should not be mistaken for a new 2016 product announcement. [prosthetic-detail]

Class II here means general requirements are supplemented by device-specific safeguards. Later 510(k) premarket notifications must address those controls, and this category is not exempt from notification. FDA describes reasonable assurance of safety and effectiveness, not certainty that every user will benefit. The order defines the legal category; VA explains the earlier technology. Both belong to the same development and regulatory history, rather than providing independent clinical replication. [2016-25001][prosthetic-detail]

Source documents

  1. Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Componentshttps://www.govinfo.gov/content/pkg/FR-2016-10-18/html/2016-25001.htm
  2. DEKA advanced prosthetic arm gains FDA approvalhttps://www.research.va.gov/currents/spring2014/spring2014-34.cfm