[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: 21CFR801.150]

[Page 22-23]
 
                        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 E--Other Exemptions
 
Sec. 801.150  Medical devices; processing, labeling, or repacking.


    (a) Except as provided by paragraphs (b) and (c) of this section, a 
shipment or other delivery of a device which is, in accordance with the 
practice of the trade, to be processed, labeled, or repacked, in 
substantial quantity at an establishment other than that where 
originally processed or packed, shall be exempt, during the time of 
introduction into and movement in interstate commerce and the time of 
holding in such establishment, from compliance with the labeling and 
packaging requirements of section 502(b) and (f) of the act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such 
device is to be processed, labeled, or repacked; or
    (2) In case such person is not such operator, such shipment or 
delivery is made to such establishment under a written agreement, signed 
by and containing the post office addresses of such person and such 
operator, and containing such specifications for the processing, 
labeling, or repacking, as the case may be, of such device in such 
establishment as will insure, if such specifications are followed, that 
such device will not be adulterated or misbranded within the meaning of 
the act upon completion of such processing, labeling, or repacking. Such 
person and such operator shall each keep a copy of such agreement until 
2 years after the final shipment or delivery of such device from such 
establishment, and shall make such copies available for inspection at 
any reasonable hour to any officer or employee of the Department who 
requests them.
    (b) An exemption of a shipment or other delivery of a device under 
paragraph (a)(1) of this section shall, at the beginning of the act of 
removing such shipment or delivery, or any part thereof, from such 
establishment, become void ab initio if the device comprising such 
shipment, delivery, or part is adulterated or misbranded within the 
meaning of the act when so removed.
    (c) An exemption of a shipment or other delivery of a device under 
paragraph (a)(2) of this section shall become void ab initio with 
respect to the person who introduced such shipment or delivery into 
interstate commerce upon refusal by such person to make available for 
inspection a copy of the agreement, as required by such paragraph 
(a)(2).
    (d) An exemption of a shipment or other delivery of a device under 
paragraph (a)(2) of this section shall expire:
    (1) At the beginning of the act of removing such shipment or 
delivery, or any part thereof, from such establishment if the device 
comprising such shipment, delivery, or part is adulterated or misbranded 
within the meaning of the act when so removed; or
    (2) Upon refusal by the operator of the establishment where such 
device is to be processed, labeled, or repacked, to make available for 
inspection a copy of the agreement, as required by such clause.
    (e) As it is a common industry practice to manufacture and/or 
assemble, package, and fully label a device as sterile at one 
establishment and then ship such device in interstate commerce to 
another establishment or to a contract sterilizer for sterilization, the 
Food and Drug Administration will initiate no regulatory action against 
the device as misbranded or adulterated when the nonsterile device is 
labeled sterile, provided all the following conditions are met:
    (1) There is in effect a written agreement which:

[[Page 23]]

    (i) Contains the names and post office addresses of the firms 
involved and is signed by the person authorizing such shipment and the 
operator or person in charge of the establishment receiving the devices 
for sterilization.
    (ii) Provides instructions for maintaining proper records or 
otherwise accounting for the number of units in each shipment to insure 
that the number of units shipped is the same as the number received and 
sterilized.
    (iii) Acknowledges that the device is nonsterile and is being 
shipped for further processing, and
    (iv) States in detail the sterilization process, the gaseous mixture 
or other media, the equipment, and the testing method or quality 
controls to be used by the contract sterilizer to assure that the device 
will be brought into full compliance with the Federal Food, Drug, and 
Cosmetic Act.
    (2) Each pallet, carton, or other designated unit is conspicuously 
marked to show its nonsterile nature when it is introduced into and is 
moving in interstate commerce, and while it is being held prior to 
sterilization. Following sterilization, and until such time as it is 
established that the device is sterile and can be released from 
quarantine, each pallet, carton, or other designated unit is 
conspicuously marked to show that it has not been released from 
quarantine, e.g., ``sterilized--awaiting test results'' or an equivalent 
designation.

Subparts F--G [Reserved]