CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR890]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
					
SUBCHAPTER H - MEDICAL DEVICES
					
							PART 890PHYSICAL MEDICINE DEVICES

Subpart D - Physical Medicine Prosthetic Devices

Sec. 890.3025 Prosthetic and orthotic accessory.

(a) Identification. A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]

Sec. 890.3075 Cane.

(a) Identification. A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of canes include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]

Sec. 890.3100 Mechanical chair.

(a) Identification. A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position and a chair with casters used by a person to move from one place to another while sitting.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38816, July 25, 2001]

Sec. 890.3110 Electric positioning chair.

(a) Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.

(b) Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:

(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;

(2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;

(3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;

(4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;

(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, "Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance," and ANSI/AAMI/IEC 60601-1-2, "Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests") must validate electromagnetic compatibility and electrical safety;

(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," ANSI/AAMI/ISO 10993-5, "Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity," and ANSI/AAMI/ISO 10993-10, "Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization") must validate that the skin-contacting components of the device are biocompatible;

(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, "Medical Device Software - Software Life Cycle Processes") must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;

(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;

(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and

(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.

[48 FR 53047, Nov. 23, 1983, as amended at 80 FR 72950, Nov. 20, 2015]

Sec. 890.3150 Crutch.

(a) Identification. A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]

Sec. 890.3175 Flotation cushion.

(a) Identification. A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001]

Sec. 890.3410 External limb orthotic component.

(a) Identification. An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]

Sec. 890.3420 External limb prosthetic component.

(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]

Sec. 890.3450 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.

(a) Identification. A 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, is a prescription device intended for medical purposes, and is intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously powered elbow and/or shoulder. Prosthetic arm components that are intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity prosthesis system.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Appropriate analysis/testing must validate electronic compatibility, electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.

(2) Appropriate software verification, validation, and hazard analysis must be performed.

(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:

(i) Mechanical bench data, including durability testing, to demonstrate that the device will withstand forces, conditions, and environments encountered during use.

(ii) Simulated use testing to demonstrate performance of arm commands and available safeguard(s) under worst case conditions and after durability testing.

(iii) Verification and validation of force sensors and hand release button, if applicable, are necessary.

(iv) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor and brake performance.

(v) The accuracy of the device features and safeguards.

(4) Non-clinical and clinical performance testing must demonstrate the accuracy of device features and safeguards.

(5) Elements of the device that may contact the patient must be demonstrated to be biocompatible.

(6) Documented clinical experience and human factors testing must demonstrate safe and effective use, capture any adverse events observed during clinical use and demonstrate the accuracy of device features and safeguards.

(7) Labeling for the Prosthetist and User Guide must include:

(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities that may put the user at greater risk (e.g., driving).

(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,

(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 maintaining the device.

(iii) Information on the patient population for which the device has been demonstrated to be effective.

(iv) A detailed summary of the non-clinical and clinical testing pertinent to use of the device.

[81 FR 71612, Oct. 18, 2016]

Sec. 890.3475 Limb orthosis.

(a) Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]

Sec. 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;

(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]

Sec. 890.3490 Truncal orthosis.

(a) Identification. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]

Sec. 890.3500 External assembled lower limb prosthesis.

(a) Identification. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]

Sec. 890.3520 Plinth.

(a) Identification. A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device for treatment or examination.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]

Sec. 890.3610 Rigid pneumatic structure orthosis.

(a) Identification. A rigid pneumatic structure orthosis is a device intended for medical purposes to provide whole body support by means of a pressurized suit to help thoracic paraplegics walk.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any rigid pneumatic structure orthosis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a rigid pneumatic structure orthosis that was in commercial distribution before May 28, 1976. Any other rigid pneumatic structure orthosis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 61 FR 50711, Sept. 27, 1996]

Sec. 890.3640 Arm sling.

(a) Identification. An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]

Sec. 890.3665 Congenital hip dislocation abduction splint.

(a) Identification. A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]

Sec. 890.3675 Denis Brown splint.

(a) Identification. A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]

Sec. 890.3690 Powered wheeled stretcher.

(a) Identification. A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).

(b) Classification. Class II (performance standards). The powered wheeled stretcher is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9, and the following conditions for exemption:

(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;

(2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;

(3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;

(4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;

(5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety;

(6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible;

(7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;

(8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable;

(9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device;

(10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and

(11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.

[48 FR 53047, Nov. 23, 1983, as amended at 85 FR 2020, Jan. 14, 2020]

Sec. 890.3700 Nonpowered communication system.

(a) Identification. A nonpowered communication system is a mechanical device intended for medical purposes that is used to assist a patient in communicating when physical impairment prevents writing, telephone use, reading, or talking. Examples of nonpowered communications systems include an alphabet board and a page turner.

[48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989; 66 FR 38817, July 25, 2001]

Sec. 890.3710 Powered communication system.

(a) Identification. A powered communication system is an AC- or battery-powered device intended for medical purposes that is used to transmit or receive information. It is used by persons unable to use normal communication methods because of physical impairment. Examples of powered communication systems include the following: a specialized typewriter, a reading machine, and a video picture and word screen.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]

Sec. 890.3725 Powered environmental control system.

(a) Identification. A powered environmental control system is an AC- or battery-powered device intended for medical purposes that is used by a patient to operate an environmental control function. Examples of environmental control functions include the following: to control room temperature, to answer a doorbell or telephone, or to sound an alarm for assistance.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]

Sec. 890.3750 Mechanical table.

(a) Identification. A mechanical table is a device intended for medical purposes that has a flat surface that can be inclined or adjusted to various positions. It is used by patients with circulatory, neurological, or musculoskeletal conditions to increase tolerance to an upright or standing position.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, 2001]

Sec. 890.3760 Powered table.

(a) Identification. A powered table is a device intended for medical purposes that is an electrically operated flat surface table that can be adjusted to various positions. It is used by patients with circulatory, neurological, or musculoskeletal conditions to increase tolerance to an upright or standing position.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38817, July 25, 2001]

Sec. 890.3790 Cane, crutch, and walker tips and pads.

(a) Identification. Cane, crutch, and walker tips and pads are rubber (or rubber substitute) device accessories intended for medical purposes that are applied to the ground end of mobility aids to prevent skidding or that are applied to the body contact area of the device for comfort or as an aid in using an ambulatory assist device.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]

Sec. 890.3800 Motorized three-wheeled vehicle.

(a) Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

(b) Classification. Class II (performance standards).

Sec. 890.3825 Mechanical walker.

(a) Identification. A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]

Sec. 890.3850 Mechanical wheelchair.

(a) Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

(b) Classification. Class I (general controls).

Sec. 890.3860 Powered wheelchair.

(a) Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

(b) Classification. Class II (performance standards).

Sec. 890.3880 Special grade wheelchair.

(a) Identification. A special grade wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is intended to be used in all environments for long-term use, e.g., for paraplegics, quadraplegics, and amputees.

(b) Classification. Class II (performance standards).

Sec. 890.3890 Stair-climbing wheelchair.

(a) Identification. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.

(2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following:

(i) Fatigue testing;

(ii) Resistance to dynamic loads (impact testing);

(iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure;

(iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral);

(v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and

(vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions.

(3) The skin-contacting components of the device must be demonstrated to be biocompatible.

(4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended.

(5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.

(6) Performance testing must demonstrate battery safety and evaluate longevity.

(7) Performance testing must evaluate the flammability of device components.

(8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following:

(i) A clear description of the technological features of the device and the principles of how the device works;

(ii) A clear description of the appropriate use environments/conditions, including prohibited environments;

(iii) Preventive maintenance recommendations;

(iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and

(v) A detailed summary of the device-related adverse events and how to report any complications.

(9) Clinician labeling must include all the information in the Patient labeling noted in paragraph (b)(8) of this section but must also include the following:

(i) Identification of patients who can effectively operate the device; and

(ii) Instructions on how to fit, modify, or calibrate the device.

(10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training.

[79 FR 20782, Apr. 14, 2014]

Sec. 890.3900 Standup wheelchair.

(a) Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

(b) Classification. Class II (performance standards).

Sec. 890.3910 Wheelchair accessory.

(a) Identification. A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

(b) Classification. Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.

[61 FR 8439, Mar. 4, 1996, as amended at 66 FR 38817, July 25, 2001]

Sec. 890.3920 Wheelchair component.

(a) Identification. A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, 2001]

Sec. 890.3930 Wheelchair elevator.

(a) Permanently mounted wheelchair platform lift - (1) Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.

(2) Classification. Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:

(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;

(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;

(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate the ability of the enclosures to prevent the user from falling from the device; and

(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, "Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests," and ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must validate electromagnetic compatibility and electrical safety.

(b) Portable wheelchair elevators - (1) Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).

(2) Classification. Class II.

[78 FR 14015, Mar. 4, 2013]

Sec. 890.3940 Wheelchair platform scale.

(a) Identification. A wheelchair platform scale is a device with a base designed to accommodate a wheelchair. It is intended for medical purposes to weigh a person who is confined to a wheelchair.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38817, July 25, 2001]

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

CFR - Code of Federal Regulations Title 21

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