[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: 21CFR814.114]

[Page 148]
 
                        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. 814.114  Timeframes for reviewing an HDE.

    Within 75 days after receipt of an HDE that is accepted for filing 
and to which the applicant does not submit a major amendment, FDA shall 
send the applicant an approval order, an approvable letter, a not 
approvable letter (under Sec. 814.116), or an order denying approval 
(under Sec. 814.118).

[63 FR 59221, Nov. 3, 1998]