[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: 21CFR860.95]

[Page 172-173]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES--Table of Contents
 
                        Subpart B--Classification
 
Sec. 860.95  Exemptions from sections 510, 519, and 520(f) of the act.

    (a) A panel recommendation to the Commissioner that a device be 
classified or reclassified into class I will include a recommendation as 
to whether the device should be exempted from some or all of the 
requirements of one or more of the following sections of the act: 
Section 510 (registration, product listing and premarket notification), 
section 519 (records and reports), and section 520(f) (good 
manufacturing practice regulations).
    (b) A regulation or an order classifying or reclassifying a device 
into class I will specify which requirements, if any, of sections 510, 
519, and 520(f) of the act the device is to be exempted from, together 
with the reasons for such exemption.
    (c) The Commissioner will grant exemptions under this section only 
if the Commissioner determines that the requirements from which the 
device is exempted are not necessary to provide

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reasonable assurance of the safety and effectiveness of the device.