[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1003.31]

[Page 609-610]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1003_NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY--
Table of Contents
 
           Subpart D_Exemptions From Notification Requirements
 
Sec. 1003.31  Granting the exemption.

    (a) If, in the judgment of the Secretary, the application filed 
pursuant to Sec. 1003.30 states reasonable grounds for an exemption 
from the requirement of notice, the Secretary shall give the 
manufacturer written notice specifying a reasonable period of time 
during which he may present his views and evidence in support of the 
application.
    (b) Such views and evidence shall be confined to matters relevant to 
whether the defect in the product or its failure to comply with an 
applicable Federal standard is such as to create a significant risk of 
injury, including genetic injury, to any person and shall be presented 
in writing unless the Secretary determines that an oral presentation is 
desirable. Where such evidence includes nonclinical laboratory studies, 
the data submitted shall include, with respect to each such study, 
either a statement that the study was conducted in compliance with the 
requirements set forth in part 58 of this chapter, or, if the study was 
not conducted in compliance with such regulations, a brief statement of 
the reason for the noncompliance. When such evidence includes clinical 
investigations involving human subjects, the data submitted shall 
include, with respect to each clinical investigation either a statement 
that each investigation was conducted in compliance with the 
requirements set forth in part 56 of this chapter, or a statement that 
the investigation is not subject to such requirements in accordance with 
Sec. 56.104 or

[[Page 610]]

Sec. 56.105, and a statement that each investigation was conducted in 
compliance with the requirements set forth in part 50 of this chapter.
    (c) If, during the period of time afforded the manufacturer to 
present his views and evidence, the manufacturer proves to the 
Secretary's satisfaction that the defect or failure to comply does not 
create a significant risk of injury, including genetic injury, to any 
person, the Secretary shall issue an exemption from the requirement of 
notification to the manufacturer and shall notify the manufacturer in 
writing specifying:
    (1) The electronic product or products for which the exemption has 
been issued; and
    (2) Such conditions as the Secretary deems necessary to protect the 
public health and safety.
    (d) Any person who contests denial of an exemption shall have an 
opportunity for a regulatory hearing before the Food and Drug 
Administration pursuant to part 16 of this chapter.

[38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 
FR 15676, Mar. 22, 1977; 50 FR 7518, Feb. 22, 1985]