[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR84.42]

[Page 516]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 84_APPROVAL OF RESPIRATORY PROTECTIVE DEVICES--Table of Contents
 
                        Subpart E_Quality Control
 
Sec. 84.42  Proposed quality control plans; approval by the Institute.

    (a) Each proposed quality control plan submitted in accordance with 
this subpart shall be reviewed by the Institute to determine its 
effectiveness in ensuring the quality of respiratory protection provided 
by the respirator for which an approval is sought.
    (b) If the Institute determines that the proposed quality control 
plan submitted by the applicant will not ensure adequate quality 
control, the Institute shall require the applicant to modify the 
procedures and testing requirements of the plan prior to approval of the 
plan and issuance of any certificate of approval.
    (c) Approved quality control plans shall constitute a part of and be 
incorporated into any certificate of approval issued by the Institute, 
and compliance with such plans by the applicant shall be a condition of 
approval.