[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR861.20]

[Page 170-171]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT--Table of Contents
 
    Subpart B--Procedures for Performance Standards Development and 
                               Publication
 
Sec. 861.20  Summary of standards development process.


    The procedure by which a performance standard for a device may be 
established, amended, or revoked is as follows:
    (a) The Food and Drug Administration (FDA) will publish in the 
Federal Register a notice of proposed rulemaking for the establishment, 
amendment, or revocation of any performance standard for a device.
    (1) A notice of proposed rulemaking for the establishment or 
amendment of a performance standard for a device will:
    (i) Set forth a finding, with supporting justification, that the 
performance standard is appropriate and necessary to provide reasonable 
assurance of the safety and effectiveness of the device;
    (ii) Set forth proposed findings with respect to the risk of illness 
or injury that the performance standard is intended to reduce or 
eliminate;
    (iii) Invite interested persons to submit to the Food and Drug 
Administration, within 30 days of the publication of the notice, 
requests for changes in the classification of the device pursuant to 
Sec. 860.132 of this chapter, based on new information relevant to the 
classification; and
    (iv) Invite interested persons to submit an existing performance 
standard for the device, including a draft or proposed performance 
standard, for consideration by the Commissioner of Food and Drugs.
    (2) A notice of proposed rulemaking for the revocation of a 
performance standard will set forth a finding, with supporting 
justification, that the performance standard is no longer necessary to 
provide reasonable assurance of the safety and effectiveness of a 
device.
    (b) A notice under this section will provide for a comment period of 
not less than 60 days.

[[Page 171]]

    (c) If, after publication of a notice under paragraph (a) of this 
section, FDA receives a request to change the classification of the 
device, FDA will, within 60 days of the publication of the notice and 
after consultation with the appropriate panel under Sec. 860.125 of this 
chapter, either deny the request or give notice of its intent to 
initiate a change in the classification under Sec. 860.130.
    (d) If FDA initiates a rulemaking proceeding under paragraph (a) of 
this section, FDA will:
    (1) Complete the proceeding and establish the performance standard 
for the device in accordance with this part and Sec. 10.40 of this 
chapter; or
    (2) Terminate the proceeding by publishing in the Federal Register a 
notice announcing such termination and the reasons therefor and, unless 
the proceeding is terminated because the device is a banned device, 
initiate a proceeding in accordance with section 513(e) of the act to 
reclassify the device; or
    (3) Take other appropriate action.

[57 FR 58404, Dec. 10, 1992]