[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.127]

[Page 21-22]
 
                        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

[[Page 22]]

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 Secs. 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.