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 Components
fda-device · Food and Drug Administration · Rule · Published 2016-10-18 · Effective 2016-10-18 · 81 FR 71610
Document
Document number
2016-25001
Federal Register citation
81 FR 71610
CFR reference
21 CFR 890
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-10-18
Effective date
2016-10-18
HHS docket
Docket No. FDA-2016-N-2829
Abstract
The Food and Drug Administration (FDA) is classifying 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 Components into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for 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 components' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.