[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.34]
[Page 241-242]
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.
[[Page 242]]
(b) Classification or reclassification of a device under part 860 of
this chapter, including the establishment of special controls, if the
action will not result in increases in the existing levels of use of the
device or changes in the intended use of the device or its substitutes.
(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.
(i) Approval of humanitarian device exemption under subpart H of
part 814 of this chapter.
[62 FR 40592, July 29, 1997, as amended at 70 FR 69277, Nov. 15, 2005]
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