{"data":{"id":"us/21-cfr-807.97","jurisdiction":"us","citation":"21 CFR 807.97","heading":"Misbranding by reference to premarket notification.","body":"Submission of a premarket notification in accordance with this subpart, and a subsequent determination by the Commissioner that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution before May 28, 1976, or is substantially equivalent to a device introduced into commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II, does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES","Subpart E—Premarket Notification Procedures"],"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":"b3ed04713ddfedf2125da50def1caa7db285bbb42da19559cd4a8a782c6f4a49","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-807.95","next":"us/21-cfr-807.100"},"notice":"GroundRules: Original legal text. Not legal advice."}