{"data":{"id":"us/21-cfr-860.200","jurisdiction":"us","citation":"21 CFR 860.200","heading":"Purpose and applicability.","body":"(a) The purpose of this part is to establish an efficient, transparent, and thorough process to facilitate De Novo classification into class I or class II for devices for which there is no legally marketed device on which to base a review of substantial equivalence and which meet the definition of class I or class II as described in section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act and § 860.3.\n(b) De Novo requests can be submitted for a single device type:\n(1) After receiving a not substantially equivalent determination in response to a premarket notification (510(k)), or\n(2) If a person determines there is no legally marketed device upon which to base a determination of substantial equivalence.","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 D—De Novo Classification"],"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":"044380cc72a3dbf9c46461b6c1d25dbeb5970e3fa0bf946a68f2efae40d5bc02","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-860.136","next":"us/21-cfr-860.210"},"notice":"GroundRules: Original legal text. Not legal advice."}