[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: 21CFR801.127]

[Page 26]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 801_LABELING--Table of Contents
 
          Subpart D_Exemptions From Adequate Directions for Use
 
Sec. 801.127  Medical devices; expiration of exemptions.

    (a) If a shipment or delivery, or any part thereof, of a device 
which is exempt under the regulations in this section is made to a 
person in whose possession the article is not exempt, or is made for any 
purpose other than those specified, such exemption shall expire, with 
respect to such shipment or delivery or part thereof, at the beginning 
of that shipment or delivery. The causing of an exemption to expire 
shall be considered an act which results in such device being misbranded 
unless it is disposed of under circumstances in which it ceases to be a 
drug or device.
    (b) The exemptions conferred by Sec. Sec. 801.119, 801.122, and 
801.125 shall continue until the devices are used for the purposes for 
which they are exempted, or until they are relabeled to comply with 
section 502(f)(1) of the act. If, however, the device is converted, or 
manufactured into a form limited to prescription dispensing, no 
exemption shall thereafter apply to the article unless the device is 
labeled as required by Sec. 801.109.