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Regulations last checked for updates: May 23, 2025

Title 42 - Public Health last revised: May 16, 2025
All TitlesTitle 42Chapter IVPart 405Subpart B - 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.
authority: 42 U.S.C. 263a,405,1302,1320b,1395x,1395y,1395ff,1395hh,1395kk,1395rr,and
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