For veterans considering an advanced prosthetic arm, regulatory status answers only part of the access question. An FDA order effective October 18, 2016, puts a class II classification and its special controls into federal regulations. The classification itself dates to May 9, 2014. This is not a new October authorization of the DEKA Arm System. [2016-25001]

The Department of Veterans Affairs’ May 2014 account illustrates the distinction. It said authorization allowed manufacturing and marketing to proceed, but that price and the timetable for reaching the market were then unclear. VA expected to offer the arm to enrolled veterans who could benefit clinically. Those were statements about 2014, not an established account of price, supply or eligibility decisions in October 2016. [prosthetic-detail]

The codified safeguards address what happens after a device reaches a user. FDA requires instructions covering fitting, controls, safety features and maintenance, along with the clinical training needed for safe use. It also requires labeling to identify the population in which effectiveness has been demonstrated. The device is prescription-only; its classification cannot determine suitability for an individual veteran. [2016-25001]

Our practical reading is to separate three questions: whether a device has a regulatory pathway, whether it fits a person’s clinical needs, and whether delivery arrangements are established. The order and VA history illuminate the first two without resolving the third for October 2016. They are complementary government records from the same development and regulatory chain, not independent clinical replications or proof of universal benefit. [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