[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.100]

[Page 139-140]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814_PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                   Subpart H_Humanitarian Use Devices
 
Sec. 814.100  Purpose and scope.

    Source: 61 FR 33244, June 26, 1996, unless otherwise noted.


    (a) This subpart H implements section 520(m) of the act. The purpose 
of section 520(m) is, to the extent consistent with the protection of 
the public health and safety and with ethical standards, to encourage 
the discovery and use of devices intended to benefit patients in the 
treatment or diagnosis of diseases or conditions that affect or are 
manifested in fewer than 4,000 individuals in the United States per 
year. This subpart provides procedures for obtaining:
    (1) HUD designation of a medical device; and
    (2) Marketing approval for the HUD notwithstanding the absence of 
reasonable assurance of effectiveness that would otherwise be required 
under sections 514 and 515 of the act.
    (b) Although a HUD may also have uses that differ from the 
humanitarian use, applicants seeking approval of any non-HUD use shall 
submit a PMA as required under Sec. 814.20, or a premarket

[[Page 140]]

notification as required under part 807 of this chapter.
    (c) Obtaining marketing approval for a HUD involves two steps:
    (1) Obtaining designation of the device as a HUD from FDA's Office 
of Orphan Products Development, and
    (2) Submitting an HDE to the Office of Device Evaluation (ODE), 
Center for Devices and Radiological Health (CDRH).
    (d) A person granted an exemption under section 520(m) of the act 
shall submit periodic reports as described in Sec. 814.126(b).
    (e) FDA may suspend or withdraw approval of an HDE after providing 
notice and an opportunity for an informal hearing.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59220, Nov. 3, 1998]