{"data":{"id":"us/21-cfr-882.4950","jurisdiction":"us","citation":"21 CFR 882.4950","heading":"Diagnostic neurosurgical microscope filter.","body":"(a) Identification. A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and verify and validate filter specifications and functional characteristics, including the following:\n(i) Spectrum and intensity of the illumination source;\n(ii) Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope;\n(iii) Excitation power and power density;\n(iv) Optical path loss from illumination source to objective lens or microscope camera;\n(v) Homogeneity of the excitation light at the focal plane;\n(vi) Fluorescence detection sensitivity;\n(vii) Verification of calibration or preoperative procedures; and\n(viii) If camera-based, spectral sensitivity of the camera.\n(2) Labeling must include:\n(i) Identification of the filter characteristics in conjunction with a compatible surgical operating microscope, to include the following:\n(A) Illumination spectrum and power density; and\n(B) Excitation and emission filter spectra.\n(ii) Instructions for calibration or preoperative checks to ensure device functionality prior to each use;\n(iii) Instructions for use with compatible surgical operating microscopes, external light sources, and cameras;\n(iv) A warning that the device should only be used with fluorophores approved for use within the specified spectral ranges; and\n(v) A warning that the device is not a standalone diagnostic.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 882—NEUROLOGICAL DEVICES","Subpart E—Neurological Surgical 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":"15dfe62c9e5537d3540a81e2dc10acc9cf01c15f0e6ee314aba8cc1a7ffe86c8","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.4900","next":"us/21-cfr-882.5030"},"notice":"GroundRules: Original legal text. Not legal advice."}