{"data":{"id":"us/21-cfr-886.5305","jurisdiction":"us","citation":"21 CFR 886.5305","heading":"Electromechanical tear stimulator.","body":"(a) Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.\n(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:\n(i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;\n(ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and\n(iii) Use life testing.\n(3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.\n(4) All patient-contacting components of the device must be demonstrated to be biocompatible.\n(5) Software verification, validation, and hazard analysis must be performed.\n(6) Physician and patient labeling must include:\n(i) A detailed summary of the device's technical parameters;\n(ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;\n(iii) Information related to electromagnetic compatibility classification;\n(iv) Instructions on how to clean and maintain the device;\n(v) A summary of the clinical performance testing conducted with the device;\n(vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and\n(vii) Information on how the device operates and the typical sensations experienced during treatment.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 886—OPHTHALMIC DEVICES","Subpart F—Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"67a47b675fd1e4193f523c59f529840c8022005a9516871142e058bf38b68a67","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-886.5300","next":"us/21-cfr-886.5310"},"notice":"GroundRules: Original legal text. Not legal advice."}