{"data":{"id":"us/21-cfr-880.1","jurisdiction":"us","citation":"21 CFR 880.1","heading":"Scope.","body":"(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution.\n(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.\n(c) To avoid duplicative listings, a general hospital and personal use device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.\n(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.\n(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES","Subpart A—General Provisions"],"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":"99a78ab004f78fbc81bc2ba8191585e767be5388d54b0ffd057d01bc80c19c0b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.5910","next":"us/21-cfr-880.3"},"notice":"GroundRules: Original legal text. Not legal advice."}