[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: 42CFR84.30]

[Page 512-513]
 
                         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 D_Approval and Disapproval
 
Sec. 84.30  Certificates of approval; scope of approval.


    (a) The Institute shall issue certificates of approval pursuant to 
the provisions of this subpart only for individual, completely assembled 
respirators which have been examined, inspected, and tested, and which 
meet the minimum requirements set forth in subparts H through L of this 
part, as applicable.
    (b) The Institute will not issue certificates of approval for any 
respirator component or for any respirator subassembly.
    (c) The Institute shall not issue an informal notification of 
approval. However, if the application for approval, submitted in 
accordance with Sec. 84.11, states that the submitted respirator and 
component parts are only prototypes, the Institute will examine, 
inspect, and test such respirator and component parts in accordance with 
the provisions of this part. If, upon completion of such examinations, 
inspections and tests, it is found that the prototype meets the minimum 
requirements set forth in this part, the Institute may inform the 
applicant, in writing, of the results of the examinations, inspections, 
and tests, and may require

[[Page 513]]

him to resubmit respirators and component parts made on regular 
production tooling, with no operations included which will not be 
incorporated in regular production processing, for further examination, 
inspection, and testing, prior to issuance of the certificate of 
approval.
    (d) Applicants required to resubmit respirators and component parts 
made on regular production tooling, with no operation included which 
will not be incorporated in regular production processing, shall be 
charged fees in accordance with subpart C of this part.