[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: 21CFR814.2]

[Page 116]
 
                        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 A--General
 
Sec. 814.2  Purpose.

    The purpose of this part is to establish an efficient and thorough 
device review process--
    (a) To facilitate the approval of PMA's for devices that have been 
shown to be safe and effective and that otherwise meet the statutory 
criteria for approval; and
    (b) To ensure the disapproval of PMA's for devices that have not 
been shown to be safe and effective or that do not otherwise meet the 
statutory criteria for approval. This part shall be construed in light 
of these objectives.