Editorial Note on Part 890
Editorial Note: Nomenclature changes to part 890 appear at 73 FR 35341, June 23, 2008.

§ 890.3480 Powered lower extremity exoskeleton. ( a ) *Identification.* A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
( 2 ) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
( 3 ) Appropriate software verification, validation, and hazard analysis must be performed.
( 4 ) Design characteristics must ensure geometry and materials composition are consistent with intended use.
( 5 ) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: ( i ) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
( ii ) Simulated use testing (*i.e.,* cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;
( iii ) Verification and validation of manual override controls are necessary, if present;
( iv ) The accuracy of device features and safeguards; and
( v ) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
( 6 ) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for: ( i ) Level of supervision necessary, and
( ii ) Environment of use (*e.g.,* indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.
( 7 ) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can: ( i ) Identify the safe environments for device use,
( ii ) Use all safety features of device, and
( iii ) Operate the device in simulated or actual use environments representative of indicated environments and use.
( 8 ) Labeling for the Physician and User must include the following: ( i ) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
( ii ) Specific instructions and the clinical training needed for the safe use of the device, which includes: ( A ) Instructions on assembling the device in all available configurations;
( B ) Instructions on fitting the patient;
( C ) Instructions and explanations of all available programs and how to program the device;
( D ) Instructions and explanation of all controls, input, and outputs;
( E ) Instructions on all available modes or states of the device;
( F ) Instructions on all safety features of the device; and
( G ) Instructions for properly maintaining the device.
( iii ) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
( iv ) Pertinent non-clinical testing information (*e.g.,* EMC, battery longevity).
( v ) A detailed summary of the clinical testing including: ( A ) Adverse events encountered under use conditions,
( B ) Summary of study outcomes and endpoints, and
( C ) Information pertinent to use of the device including the conditions under which the device was studied (*e.g.,* level of supervision or assistance, and environment of use (*e.g.,* indoors and/or outdoors) including obstacles and terrain).
[80 FR 25529, May 4, 2015]