Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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 manufacturer’s 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