Compliance Policy Guide 
Sec. 390.200 Determination by Secretary that Product Fails to 
Comply or has Defect - 21 CFR 1003.11 
 
Guidance for FDA Staff 
 
This document supersedes Sec. 390.200 Determination by Secretary that Product 
Fails to Comply or has Defect  21 CFR 1003.11, previously revised on 03/1995. 
  
 
Issued by: 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
11/2012 
 
This guidance represents the Food and Drug Administration's (FDA's)  current 
thinking on  this topic. It does not create or confer any rights for or on  any person  
and does not operate to bind FDA or the public. You can use an alternative 
approach if the approach satisfies the requirements of the applicable statutes and 
regulations. If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing  this guidance. If  you cannot  identify the appropriate 
FDA staff, call the telephone number listed on the title page of this guidance. 
 
 
I. Introduction: 
 
This document is intended for FDA staff, regulated manufacturers, and the general 
public.  This document  clarifies the scope of a manufacturers responsibility for the 
radiation safety of their electronic products. 
  
FDA's guidance documents, including this guidance, do not establish legally  
enforceable responsibilities. Instead, guidances describe the Agency's current 
thinking on  a topic and should be viewed only as recommendations, unless specific  
regulatory or statutory requirements are cited. The use of the word should in Agency 
guidances means that something is suggested or recommended, but not required.  
 
II. Background: 
 
Section 535(e) of the Federal Food, Drug, and  Cosmetic Act, (Act) Subchapter C-
Electronic Product Radiation Control (P.L. 90-602), and 1003.11 of the implementing 
regulations (21 CFR 1003.11) state that if the Food and Drug Administration 
determines that any electronic product either does not comply with an applicable  
Federal performance standard, or has a defect that relates to the safety or use of 
such product, the manufacturer shall immediately be notified in writing of  the alleged 
defect or noncompliance, the findings of  the FDA, and all information on  which  the 
findings are based. The notification shall also state a reasonable period of time 
during which the manufacturer may present his view and evidence to establish that  there is no failure of compliance, or that the alleged defect does not exist. If the  FDA 
alleges a defect or failure to comply which the manufacturer believes was caused by 
the user rather than  through any fault in design, production, or assembly, the  
manufacturer will have an opportunity to present evidence in substantiation of his 
position. 
 
III Policy: 
 
*A manufacturer of electronic products is responsible for all defects or failures to 
comply which are the result of design,  production, or assembly.* However, if it can  
be shown that a product no longer meets the requirements of a performance 
standard because of modification of the equipment by unauthorized personnel,  
installation of improper replacement parts or materials, or unforeseeable abuse of 
the equipment by the owner or user, there may be a basis for a finding that certain 
of the notification requirements and the  repair, replace and refund provisions (21 
CFR 1003 and 1004) will not apply. 
 
The manufacturer bears the burden of proof in  establishing that a defect or *failure 
to comply is due to a cause other than faulty design, production, or assembly.* The 
FDA's mandate to protect the public health and safety under P.L. 90-602, together 
with the Act's specification that measures to enforce the control of electronic product 
radiation be directed against the manufacturer of a product, requires that the 
primary responsibility of a manufacturer for the safety of  his product  not be lifted  
unless the responsibility can clearly be placed on another. FDA will refrain from 
requiring the manufacturer to repair, replace, or refund only in those situations 
where there is no reasonable basis for believing that a violation of the Act resulted 
from a manufacturer's act or omission. 
 
For example, a certain amount of  normal wear will occur in electronic products. If  
such normal wear results in radiation emitted by the product exceeding the limit  
prescribed in an applicable standard, the manufacturer may be charged with *a  
failure to comply* because of his failure to design the product to maintain an  
acceptable level of radiation emission over its useful life. The distinction between 
normal wear and damage resulting from misuse of the equipment is something which  
the manufacturer would have to justify. Similarly, a manufacturer will be held 
responsible when he fails to act reasonably to inform users of the equipment and 
service personnel of the need for, and methods of proper servicing. 
 
Issued: 8/23/1974 
Reissued: 6/11/1976 
Revised: 10/1/1980, 9/24/1987, 3/1995, 11/2012