[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.104]

[Page 146-147]
 
                        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. 814.104  Original applications.

    (a) United States applicant or representative. The applicant or an 
authorized representative shall sign the HDE. If the applicant does not 
reside or have a place of business within the United States, the HDE 
shall be countersigned by an authorized representative residing or 
maintaining a place of business in the United States and shall identify 
the representative's name and address.
    (b) Contents. Unless the applicant justifies an omission in 
accordance with paragraph (d) of this section, an HDE shall include:
    (1) A copy of or reference to the determination made by FDA's Office 
of Orphan Products Development (in accordance with Sec. 814.102) that 
the device qualifies as a HUD;
    (2) An explanation of why the device would not be available unless 
an HDE were granted and a statement that no comparable device (other 
than another HUD approved under this subpart or a device under an 
approved IDE) is available to treat or diagnose the disease or 
condition. The application also shall contain a discussion of the risks 
and benefits of currently available devices or alternative forms of 
treatment in the United States;
    (3) An explanation of why the probable benefit to health from the 
use of the device outweighs the risk of injury or illness from its use, 
taking into account the probable risks and benefits of currently 
available devices or alternative forms of treatment. Such explanation 
shall include a description, explanation, or theory of the underlying 
disease process or condition, and known or postulated mechanism(s) of

[[Page 147]]

action of the device in relation to the disease process or condition;
    (4) All of the information required to be submitted under Sec. 
814.20(b), except that:
    (i) In lieu of the summaries, conclusions, and results from clinical 
investigations required under Sec. Sec. 814.20(b)(3)(v)(B), (b)(3)(vi), 
and (b)(6)(ii), the applicant shall include the summaries, conclusions, 
and results of all clinical experience or investigations (whether 
adverse or supportive) reasonably obtainable by the applicant that are 
relevant to an assessment of the risks and probable benefits of the 
device; and
    (ii) In addition to the proposed labeling requirement set forth in 
Sec. 814.20(b)(10), the labeling shall bear the following statement: 
Humanitarian Device. Authorized by Federal law for use in the [treatment 
or diagnosis] of [specify disease or condition]. The effectiveness of 
this device for this use has not been demonstrated; and
    (5) The amount to be charged for the device and, if the amount is 
more than $250, a report by an independent certified public accountant, 
made in accordance with the Statement on Standards for Attestation 
established by the American Institute of Certified Public Accountants, 
or in lieu of such a report, an attestation by a responsible individual 
of the organization, verifying that the amount charged does not exceed 
the costs of the device's research, development, fabrication, and 
distribution. If the amount charged is $250 or less, the requirement for 
a report by an independent certified public accountant or an attestation 
by a responsible individual of the organization is waived.
    (c) Omission of information. If the applicant believes that certain 
information required under paragraph (b) of this section is not 
applicable to the device that is the subject of the HDE, and omits any 
such information from its HDE, the applicant shall submit a statement 
that identifies and justifies the omission. The statement shall be 
submitted as a separate section in the HDE and identified in the table 
of contents. If the justification for the omission is not accepted by 
the agency, FDA will so notify the applicant.
    (d) Address for submissions and correspondence. Copies of all 
original HDE's, amendments and supplements, as well as any 
correspondence relating to an HDE, shall be sent or delivered to the 
Document Mail Center (HFZ-401), Office of Device Evaluation, Center for 
Devices and Radiological Health, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850.

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