§886.5305. Electromechanical tear stimulator.
21 C.F.R. § 886.5305
Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.
Classification. Class II (special controls). The special controls for this device are:
Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.
Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
Use life testing.
Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.
All patient-contacting components of the device must be demonstrated to be biocompatible.
Software verification, validation, and hazard analysis must be performed.
Physician and patient labeling must include:
A detailed summary of the device's technical parameters;
Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;
Information related to electromagnetic compatibility classification;
Instructions on how to clean and maintain the device;
A summary of the clinical performance testing conducted with the device;
Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and
Information on how the device operates and the typical sensations experienced during treatment.
Notes, amendments, and revision history
Amendments
[87 FR 9243, Feb. 18, 2022]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.
Amendments
[87 FR 9243, Feb. 18, 2022]