Code of Federal Regulations > Title 42 > Chapter IV > Part 405 > Subpart B - Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

§ 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.