[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: 21CFR1003.21]

[Page 579]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1003--NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY--Table of Contents
 
                         Subpart C--Notification
 
Sec. 1003.21  Notification by the manufacturer to affected persons.

    (a) The notification to the persons specified in Sec. 1003.10(b) 
shall be in writing and, in addition to other relevant information which 
the Secretary may require, shall include:
    (1) The information prescribed by Sec. 1003.20 (a), (d), and 
instructions with respect to the use of the product pending the 
correction of the defect;
    (2) A clear evaluation in nontechnical terms of the hazards 
reasonably related to any defect or failure to comply; and
    (3) The following statement:

    The manufacturer will, without charge, remedy the defect or bring 
the product into compliance with each applicable Federal standard in 
accordance with a plan to be approved by the Secretary of Health and 
Human Services, the details of which will be included in a subsequent 
communication to you.


Provided, That if at the time the notification is sent, the Secretary 
has approved a plan for the repair, replacement or refund of the 
product, the notification may include the details of the approved plan 
in lieu of the above statement.
    (b) The envelope containing the notice shall not contain advertising 
or other extraneous material, and such mailings will be made in 
accordance with this section.
    (1) No. 10 white envelopes shall be used, and the name and address 
of the manufacturer shall appear in the upper left corner of the 
envelope.
    (2) The following statement is to appear in the far left third of 
the envelope in the type and size indicated and in reverse printing, 
centered in a red rectangle 3\3/4\ inches wide and 2\1/4\ inches high:

             Important--Electronic Product Radiation Warning

The statement shall be in three lines, all capitals, and centered. 
``Important'' shall be in 36-point Gothic Bold type. ``Electronic 
Product'' and ``Radiation Warning'' shall be in 36-point Gothic 
Condensed type.

    (3) Envelopes with markings similar to those prescribed in this 
section shall not be used by manufacturers for mailings other than those 
required by this part.
    (c) The notification shall be sent:
    (1) By certified mail to purchasers of the product and to subsequent 
transferees.
    (2) By certified mail or other more expeditious means to dealers and 
distributors.
    (d) Where products were sold under a name other than that of the 
manufacturer of the product, the name of the individual or company under 
whose name the product was sold may be used in the notification required 
by this section.