[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: 21CFR814.3]

[Page 124-125]
 
                        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. 814.3  Definitions.

    For the purposes of this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 
201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)).
    (b) FDA means the Food and Drug Administration.
    (c) IDE means an approved or considered approved investigational 
device exemption under section 520(g) of the act and parts 812 and 813.
    (d) Master file means a reference source that a person submits to 
FDA. A

[[Page 125]]

master file may contain detailed information on a specific manufacturing 
facility, process, methodology, or component used in the manufacture, 
processing, or packaging of a medical device.
    (e) PMA means any premarket approval application for a class III 
medical device, including all information submitted with or incorporated 
by reference therein. ``PMA'' includes a new drug application for a 
device under section 520(1) of the act.
    (f) PMA amendment means information an applicant submits to FDA to 
modify a pending PMA or a pending PMA supplement.
    (g) PMA supplement means a supplemental application to an approved 
PMA for approval of a change or modification in a class III medical 
device, including all information submitted with or incorporated by 
reference therein.
    (h) Person includes any individual, partnership, corporation, 
association, scientific or academic establishment, Government agency, or 
organizational unit thereof, or any other legal entity.
    (i) Statement of material fact means a representation that tends to 
show that the safety or effectiveness of a device is more probable than 
it would be in the absence of such a representation. A false affirmation 
or silence or an omission that would lead a reasonable person to draw a 
particular conclusion as to the safety or effectiveness of a device also 
may be a false statement of material fact, even if the statement was not 
intended by the person making it to be misleading or to have any 
probative effect.
    (j) 30-day PMA supplement means a supplemental application to an 
approved PMA in accordance with Sec. 814.39(e).
    (k) Reasonable probability means that it is more likely than not 
that an event will occur.
    (l) Serious, adverse health consequences means any significant 
adverse experience, including those which may be either life-threatening 
or involve permanent or long term injuries, but excluding injuries that 
are nonlife-threatening and that are temporary and reasonably 
reversible.
    (m) HDE means a premarket approval application submitted pursuant to 
this subpart seeking a humanitarian device exemption from the 
effectiveness requirements of sections 514 and 515 of the act as 
authorized by section 520(m)(2) of the act.
    (n) HUD (humanitarian use device) means a medical device intended to 
benefit patients in the treatment or diagnosis of a disease or condition 
that affects or is manifested in fewer than 4,000 individuals in the 
United States per year.

[51 FR 26364, July 22, 1986, as amended at 61 FR 15190, Apr. 5, 1996; 61 
FR 33244, June 26, 1996]