{"data":{"id":"us/21-cfr-884.2990","jurisdiction":"us","citation":"21 CFR 884.2990","heading":"Breast lesion documentation system.","body":"(a) Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.\n(b) Classification. Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart C—Obstetrical and Gynecological Monitoring 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":"1f6e4fac510ae681c9d364e967ef4615e47c164ebbc9db55f0da17884763172c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.2982","next":"us/21-cfr-884.3200"},"notice":"GroundRules: Original legal text. Not legal advice."}