[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.34]

[Page 246]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents
 
                    Subpart C--Categorical Exclusions
 
Sec. 25.34  Devices and electronic products.

    The classes of actions listed in this section are categorically 
excluded and, therefore, ordinarily do not require the preparation of an 
EA or an EIS:
    (a) Action on a device premarket notification submission under 
subpart E of part 807 of this chapter.
    (b) Classification or reclassification of a device under part 860 of 
this chapter.
    (c) Issuance, amendment, or repeal of a standard for a class II 
medical device or an electronic product, and issuance of exemptions or 
variances from such a standard.
    (d) Approval of a PMA or a notice of completion of a PDP or amended 
or supplemental applications or notices for a class III medical device 
if the device is of the same type and for the same use as a previously 
approved device.
    (e) Changes in the PMA or a notice of completion of a PDP for a 
class III medical device that do not require submission of an amended or 
supplemental application or notice.
    (f) Issuance of a restricted device regulation if it will not result 
in increases in the existing levels of use or changes in the intended 
uses of the product or its substitutes.
    (g) Action on an application for an IDE or an authorization to 
commence a clinical investigation under an approved PDP.
    (h) Issuance of a regulation exempting from preemption a requirement 
of a State or political subdivision concerning a device, or a denial of 
an application for such exemption.