{"data":{"id":"us/21-cfr-860.120","jurisdiction":"us","citation":"21 CFR 860.120","heading":"General.","body":"(a) Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act provide for reclassification of a device and prescribe the procedures to be followed to effect reclassification. The purposes of subpart C are to:\n(1) Set forth the requirements as to form and content of petitions for reclassification;\n(2) Describe the circumstances in which each of the five statutory reclassification provisions applies; and\n(3) Explain the procedure for reclassification prescribed in the five statutory reclassification provisions.\n(b) The criteria for determining the proper class for a device are set forth in § 860.3(c). The reclassification of any device within a generic type of device causes the reclassification of all devices within that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all devices within the same generic type.\n(c) Any interested person may submit a petition for reclassification under section 513(e), 514(b), or 515(b) of the Federal Food, Drug, and Cosmetic Act. A manufacturer or importer may submit a petition for reclassification under section 513(f) or 520(l) of the Federal Food, Drug, and Cosmetic Act. The Commissioner may initiate the reclassification of a device under the following sections of the Federal Food, Drug, and Cosmetic Act:\n(1) Section 513(e) (for a classified device other than a device classified into class III under section 513(f)(1) or 520(l)(1) of the Federal Food, Drug, and Cosmetic Act);\n(2) Section 513(f)(3) (for a device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act); or\n(3) Section 520(l)(2) (for a device classified into class III under section 520(l)(1) of the Federal Food, Drug, and Cosmetic Act).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES","Subpart C—Reclassification"],"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":"8c006e65706c5f0f2fc3dc02ea7681ae65b86356810594255c41a1f5930dadea","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-860.90","next":"us/21-cfr-860.123"},"notice":"GroundRules: Original legal text. Not legal advice."}