[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.106]

[Page 133-134]
 
                        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. 814.106  HDE amendments and resubmitted HDE's.

    An HDE or HDE supplement may be amended or resubmitted upon an 
applicant's own initiative, or at the request of FDA, for the same 
reasons and in the same manner as prescribed for PMA's in Sec. 814.37, 
except that the timeframes set forth in Sec. 814.37(c)(1) and (d) do not 
apply. If FDA requests an HDE applicant to submit an HDE amendment, and 
a written response to FDA's request is not received within 75 days of 
the date of the request, FDA will consider the pending HDE or HDE 
supplement to be withdrawn voluntarily by the applicant. Furthermore, if 
the HDE applicant, on its own initiative or at FDA's request, submits a 
major amendment as described in

[[Page 134]]

Sec. 814.37(c)(1), the review period may be extended up to 75 days.

[63 FR 59220, Nov. 3, 1998]