[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1002.50]

[Page 584-585]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1002--RECORDS AND REPORTS--Table of Contents
 
       Subpart F--Exemptions From Records and Reports Requirements
 
Sec. 1002.50  Special exemptions.


    (a) Manufacturers of electronic products may submit to the Director 
a request, together with accompanying justification, for exemption from 
any requirements listed in table 1 of Sec. 1002.1. The request must 
specify each requirement from which an exemption is requested. In 
addition to other information that is required, the justification must 
contain documented evidence showing that the product or product type for 
which the exemption is requested does not pose a public health risk and 
meets at least one of the following criteria:
    (1) The products cannot emit electronic product radiation in 
sufficient intensity or of such quality, under any conditions of 
operation, maintenance, service, or product failure, to be hazardous;
    (2) The products are produced in small quantities;
    (3) The products are used by trained individuals and are to be used 
by the same manufacturing corporation or for research, investigation, or 
training.
    (4) The products are custom designed and used by trained individuals 
knowledgeable of the hazards; or
    (5) The products are produced in such a way that the requirements 
are inappropriate or unnecessary.
    (b) The Director may, subject to any conditions that the Director 
deems necessary to protect the public health, exempt manufacturers from 
all or part

[[Page 585]]

of the record and reporting requirements of this part on the basis of 
information submitted in accordance with paragraph (a) of this section 
or such other information which the Director may possess if the Director 
determines that such exemption is in keeping with the purposes of the 
Act.
    (c) The Director will provide written notification of the reason for 
any denial. If the exemption is granted, the Director will provide 
written notification of:
    (1) The electronic product or products for which the exemption has 
been granted;
    (2) The requirements from which the product is exempted; and
    (3) Such conditions as are deemed necessary to protect the public 
health and safety. Copies of exemptions shall be available upon request 
from the Office of Compliance (HFZ-307), Center for Devices and 
Radiological Health, 2098 Gaither Rd., Rockville, MD 20850.
    (d) The Director may, on the Director's own motion, exempt certain 
classes of products from the reporting requirements listed in table 1 of 
Sec. 1002.1, provided that the Director finds that such exemption is in 
keeping with the purposes of the act.
    (e) Manufacturers of products for which there is no applicable 
performance standard under parts 1020 through 1050 of this chapter and 
for which an investigational device exemption has been approved under 
Sec. 812.30 of this chapter or for which a premarket approval 
application has been approved in accordance with Sec. 814.44(d) of this 
chapter are exempt from submitting all reports listed in table 1 of 
Sec. 1002.1.

[60 FR 48387, Sept. 19, 1995]