C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & 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

42 C.F.R. § 405.203

FDA categorization of investigational devices

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(a) The FDA assigns a device with an FDA-approved IDE to one of two categories:

(1) Category A (Experimental) devices.

(2) Category B (Nonexperimental/investigational) devices.

(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).

(c) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013
Notes of Decisions
Cited in 1 case, 2006–2006 · leading case: Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006).
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Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006). “See 42 C.F.R. §§ 405.203 , 405.205, 405.211; see also 61 Fed.”
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