{"data":{"id":"us/42-cfr-405.203","jurisdiction":"us","citation":"42 CFR 405.203","heading":"FDA categorization of investigational devices.","body":"(a) The FDA assigns a device with an FDA-approved IDE to one of two categories:\n(1) Category A (Experimental) devices.\n(2) Category B (Nonexperimental/investigational) devices.\n(b) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category A (Experimental) or Category B (Nonexperimental).\n(c) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.","path":["Title 42—Public Health","CHAPTER IV—CENTERS FOR MEDICARE \u0026 MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER B—MEDICARE PROGRAM","PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED","Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-42.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:11Z","sha256":"01e0c6c01995ba0bd235f212216f48ae1583b24607afcbcab802e54cfbf583eb","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-405.201","next":"us/42-cfr-405.205"},"notice":"GroundRules: Original legal text. Not legal advice."}