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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Jul 11, 2020
Subpart B - Medical Services Coverage Decisions That Relate to Health Care Technology
§ 405.201 - Scope of subpart and definitions.
§ 405.203 - FDA categorization of investigational devices.
§ 405.205 - Coverage of a Category B (Nonexperimental/investigational) device.
§ 405.207 - Services related to a noncovered device.
§ 405.209 - Payment for a Category B (Nonexperimental/investigational) device.
§ 405.211 - Coverage of items and services in FDA-approved IDE studies.
§ 405.212 - Medicare Coverage IDE study criteria.
§ 405.213 - Re-evaluation of a device categorization.
§ 405.215 - Confidential commercial and trade secret information.
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