[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: 21CFR814.112]

[Page 142]
 
                        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. 814.112  Filing an HDE.

    (a) The filing of an HDE means that FDA has made a threshold 
determination that the application is sufficiently complete to permit 
substantive review. Within 30 days from the date an HDE is received by 
FDA, the agency will notify the applicant whether the application has 
been filed. FDA may refuse to file an HDE if any of the following 
applies:
    (1) The application is incomplete because it does not on its face 
contain all the information required under Sec. 814.104(b);
    (2) FDA determines that there is a comparable device available 
(other than another HUD approved under this subpart or a device under an 
approved IDE) to treat or diagnose the disease or condition for which 
approval of the HUD is being sought; or
    (3) The application contains an untrue statement of material fact or 
omits material information.
    (4) The HDE is not accompanied by a statement of either 
certification or disclosure, or both, as required by part 54 of this 
chapter.
    (b) The provisions contained in Sec. 814.42(b), (c), and (d) 
regarding notification of filing decisions, filing dates, the start of 
the 75-day review period, and applicant's options in response to FDA 
refuse to file decisions shall apply to HDE's.

[61 FR 33244, June 26, 1996, as amended at 63 FR 5254, Feb. 2, 1998; 63 
FR 59221, Nov. 3, 1998]