[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.102]

[Page 131-132]
 
                        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. 814.102  Designation of HUD status.

    (a) Request for designation. Prior to submitting an HDE application, 
the applicant shall submit a request for HUD

[[Page 132]]

designation to FDA's Office of Orphan Products Development. The request 
shall contain the following:
    (1) A statement that the applicant requests HUD designation for a 
rare disease or condition or a valid subset of a disease or condition 
which shall be identified with specificity;
    (2) The name and address of the applicant, the name of the 
applicant's primary contact person and/or resident agent, including 
title, address, and telephone number;
    (3) A description of the rare disease or condition for which the 
device is to be used, the proposed indication or indications for use of 
the device, and the reasons why such therapy is needed. If the device is 
proposed for an indication that represents a subset of a common disease 
or condition, a demonstration that the subset is medically plausible 
should be included;
    (4) A description of the device and a discussion of the scientific 
rationale for the use of the device for the rare disease or condition; 
and
    (5) Documentation, with appended authoritative references, to 
demonstrate that the device is designed to treat or diagnose a disease 
or condition that affects or is manifested in fewer than 4,000 people in 
the United States per year. If the device is for diagnostic purposes, 
the documentation must demonstrate that fewer than 4,000 patients per 
year would be subjected to diagnosis by the device in the United States. 
Authoritative references include literature citations in specialized 
medical journals, textbooks, specialized medical society proceedings, or 
governmental statistics publications. When no such studies or literature 
citations exist, the applicant may be able to demonstrate the prevalence 
of the disease or condition in the United States by providing credible 
conclusions from appropriate research or surveys.
    (b) FDA action. Within 45 days of receipt of a request for HUD 
designation, FDA will take one of the following actions:
    (1) Approve the request and notify the applicant that the device has 
been designated as a HUD based on the information submitted;
    (2) Return the request to the applicant pending further review upon 
submission of additional information. This action will ensue if the 
request is incomplete because it does not on its face contain all of the 
information required under Sec. 814.102(a). Upon receipt of this 
additional information, the review period may be extended up to 45 days; 
or
    (3) Disapprove the request for HUD designation based on a 
substantive review of the information submitted. FDA may disapprove a 
request for HUD designation if:
    (i) There is insufficient evidence to support the estimate that the 
disease or condition for which the device is designed to treat or 
diagnose affects or is manifested in fewer than 4,000 people in the 
United States per year;
    (ii) FDA determines that, for a diagnostic device, 4,000 or more 
patients in the United States would be subjected to diagnosis using the 
device per year; or
    (iii) FDA determines that the patient population defined in the 
request is not a medically plausible subset of a larger population.
    (c) Revocation of designation. FDA may revoke a HUD designation if 
the agency finds that:
    (1) The request for designation contained an untrue statement of 
material fact or omitted material information; or
    (2) Based on the evidence available, the device is not eligible for 
HUD designation.
    (d) Submission. The applicant shall submit two copies of a 
completed, dated, and signed request for HUD designation to: Office of 
Orphan Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857.