[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: 21CFR814.1]

[Page 129-130]
 
                        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. 814.1  Scope.




                            Subpart A_General

Sec.
814.1 Scope.
814.2 Purpose.
814.3 Definitions.
814.9 Confidentiality of data and information in a premarket approval 
          application (PMA) file.
814.15 Research conducted outside the United States.
814.17 Service of orders.
814.19 Product development protocol (PDP).

             Subpart B_Premarket Approval Application (PMA)

814.20 Application.
814.37 PMA amendments and resubmitted PMA's.
814.39 PMA supplements.

                      Subpart C_FDA Action on a PMA

814.40 Time frames for reviewing a PMA.
814.42 Filing a PMA.
814.44 Procedures for review of a PMA.
814.45 Denial of approval of a PMA.
814.46 Withdrawal of approval of a PMA.
814.47 Temporary suspension of approval of a PMA.

Subpart D--Administrative Review [Reserved]

                   Subpart E_Postapproval Requirements

814.80 General.
814.82 Postapproval requirements.
814.84 Reports.

Subparts F-G [Reserved]

                   Subpart H_Humanitarian Use Devices

814.100 Purpose and scope.
814.102 Designation of HUD status.
814.104 Original applications.
814.106 HDE amendments and resubmitted HDE's.
814.108 Supplemental applications.
814.110 New indications for use.
814.112 Filing an HDE.
814.114 Timeframes for reviewing an HDE.

[[Page 130]]

814.116 Procedures for review of an HDE.
814.118 Denial of approval or withdrawal of approval of an HDE.
814.120 Temporary suspension of approval of an HDE.
814.122 Confidentiality of data and information.
814.124 Institutional Review Board requirements.
814.126 Postapproval requirements and reports.

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 
374, 375, 379, 379e, 381.

    Source: 51 FR 26364, July 22, 1986, unless otherwise noted.



    (a) This part implements section 515 of the act by providing 
procedures for the premarket approval of medical devices intended for 
human use.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (c) This part applies to any class III medical device, unless exempt 
under section 520(g) of the act, that:
    (1) Was not on the market (introduced or delivered for introduction 
into commerce for commercial distribution) before May 28, 1976, and is 
not substantially equivalent to a device on the market before May 28, 
1976, or to a device first marketed on, or after that date, which has 
been classified into class I or class II; or
    (2) Is required to have an approved premarket approval application 
(PMA) or a declared completed product development protocol under a 
regulation issued under section 515(b) of the act; or
    (3) Was regulated by FDA as a new drug or antibiotic drug before May 
28, 1976, and therefore is governed by section 520(1) of the act.
    (d) This part amends the conditions to approval for any PMA approved 
before the effective date of this part. Any condition to approval for an 
approved PMA that is inconsistent with this part is revoked. Any 
condition to approval for an approved PMA that is consistent with this 
part remains in effect.