§ 886.5305. Electromechanical tear stimulator.
266 words·~1 min read·
/us/cfr/t21/s§ 886.5305·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.
(2)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
(i)An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
(ii)Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
(iii)Use life testing.
(3)Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility
(EMC)of all electrical components of the device.
(4)All patient-contacting components of the device must be demonstrated to be biocompatible.
(5)Software verification, validation, and hazard analysis must be performed.
(6)Physician and patient labeling must include:
(i)A detailed summary of the device's technical parameters;
(ii)Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;
(iii)Information related to electromagnetic compatibility classification;
(iv)Instructions on how to clean and maintain the device;
(v)A summary of the clinical performance testing conducted with the device;
(vi)Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and
(vii)Information on how the device operates and the typical sensations experienced during treatment. [87 FR 9243, Feb. 18, 2022]
Connections1 cite this
Cited by 1 section
Citation graph
cites case law
§ 886.5305
Electromechanical tear stimulator.
Fed. Reg.×1
Cites 0Cited by 1 across 1 source