Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA 
Staff 
 
Information Disclosure by 
Manufacturers to Assemblers for 
Diagnostic X-ray Systems 
 
 
 
Document Issued on: September 5, 2003 
 
 
 
This document supersedes Information Disclosure by Manufacturers to 
Assemblers for Diagnostic X-ray Systems issued on April 2, 2001 
 
 
For questions regarding this document contact Thomas M. Jakub at 301-594-4591 ext. 151 or 
TMJ@CDRH.FDA.GOV.  
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
 
Diagnostic Devices Branch 
Division of Enforcement B 
Office of Compliance 
  Contains Nonbinding Recommendations 
Preface 
 
 
Public Comment 
 
 
Written comments and suggestions may be submitted at any time for Agency consideration to 
Dockets Management Branch, Division of Management Systems and Policy, Office of Human 
Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 
1061, (HFA-305), Rockville, MD, 20852.  Alternatively, electronic comments may be submitted to 
http://www.fda.gov/dockets/ecomments.  Please identify your comments with the docket number 
listed in the notice of availability that publishes in the Federal Register announcing the availability of 
this guidance document.  Comments may not be acted upon by the Agency until the document is 
next revised or updated.   
 
 
Additional Copies 
 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/comp/guidance/2619.pdf. or to receive this document via your fax 
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone.  Press 1 to enter the system.  At the second voice prompt, press 1 to order a 
document.  Enter the document number (2619) followed by the pound sign (#).  Follow the 
remaining voice prompts to complete your request.  
  ii  Contains Nonbinding Recommendations 
Guidance for Industry and FDA Staff 
 
Information Disclosure by Manufacturers 
to Assemblers for Diagnostic X-ray Systems 
  
 
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 appropriate number 
listed on the title page of this guidance.  
 
Introduction  
 
This document provides guidance to assemblers and manufacturers of diagnostic x-ray systems 
regarding the disclosure of specifications for assembly, installation, adjustment, and testing (AIAT).  
The guidance clarifies the scope and terms of the information disclosure provision and explains how 
affected parties should view cost and software issues.  This revision further clarifies that 
manufacturers should provide, upon request, AIAT information for each certified component used 
for the controlled production of x-rays. 
 
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. 
 
The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe need to be addressed 
before your device can be marketed.  In developing the guidance, we carefully considered the 
relevant statutory criteria for Agency decision-making.  We also considered the burden that may be 
incurred in your attempt to comply with the guidance and address the issues we have identified.  We 
believe that we have considered the least burdensome approach to resolving the issues presented in 
the guidance document.  If, however, you believe that there is a less burdensome way to address the 
  1  Contains Nonbinding Recommendations 
issues, you should follow the procedures outlined in the A Suggested Approach to Resolving Least 
Burdensome Issues document.  It is available on our Center web page at:  
http://www.fda.gov/cdrh/modact/leastburdensome.html. 
 
 
SUMMARY: 
 
Manufacturers of diagnostic x-ray systems are subject to information disclosure obligations so that 
assemblers or other interested parties may obtain, upon request, information regarding the assembly, 
installation, adjustment, and testing (AIAT) of an x-ray system to ensure it meets federal 
performance standards.  (21 Code of Federal Regulations sec. 1020.30(g))  The AIAT information 
should be provided at a cost not to exceed the cost of publication and distribution.  The information 
helps to ensure compliance with performance standards that are intended to reduce unnecessary x-
ray exposure to the patient and operator.  With the evolution of new technology for x-ray systems 
and related major components, the Food and Drug Administration (FDA) has received new 
questions about the scope of the information disclosure obligation for manufacturers, and whether 
computerization of that information affects the disclosure provision and how to calculate its cost.   
 
Background 
 
FDA protects the public health from unnecessary exposure to electronic product radiation by, 
among other things, requiring that electronic products meet performance standards.  (Section 532 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ii))  Federal regulations 
regarding the disclosure of AIAT information protect the public health by preventing unnecessary 
exposure to x-rays from diagnostic x-ray systems.  This disclosure obligation became effective on 
August 1, 1974.  (38 Federal Register 15444)  During that time, AIAT documentation for 
operational activities has evolved from the use of written manuals to computer software programs. 
 
Assembly of Components 
 
Assembly procedures can affect whether a diagnostic x-ray system complies with federal 
performance standards.  Accordingly, the manufacturing process is not complete until the assembler 
has installed the component(s) into an x-ray system.  The standard defines "manufacturer" to include 
"assembler."  This means that the component manufacturer can only certify to a components ability 
to function in compliance with the standard when the system is properly assembled and installed 
according to the manufacturers instructions.  A manufacturers labeled certification of a component, 
coupled with adequate and complete assembly, installation, adjustment, and testing (AIAT) 
instructions, should provide the assembler with all of the information necessary to ensure the 
products will comply with applicable performance standards when assembled, installed, adjusted 
and tested, as directed by the instructions.  Delivering a diagnostic x-ray system fully assembled 
does not relieve manufacturers of their obligations under 21 CFR 1020.30(g) to provide assemblers 
and others with AIAT materials. 
 
 
  2  Contains Nonbinding Recommendations 
 
Installation of Components 
 
The component manufacturer should also provide AIAT instructions that describe how to install the 
assembled components so the unit meets applicable performance standards.  For example, in order 
to install components properly as part of a system, the assembler needs to fix and align the 
relationship between the x-ray source and the related components of the diagnostic system.  This 
activity involves adjustment and testing to ensure compliance with performance standards.  If the 
assembler follows the AIAT instructions and the certified component does not meet the 
performance standard, the component manufacturer should, at no cost to the user, repair or replace 
the violative component(s), or refund the cost of the component. 
 
Legal Responsibility 
 
Manufacturers and assemblers each bear legal responsibility for their roles in the manufacture and 
commerce of products subject to section 1020.30.  (See sections 535(e) and 538 of the act (21 
U.S.C. 360ll(e), 360oo).)  As a practical matter, close cooperation between the manufacturer and 
the assembler furthers the interests of both parties by controlling legal liability for noncompliant or 
defective x-ray equipment. 
 
Guidance 
 
The manufacturer can certify that the components or system manufactured meet the applicable 
federal performance standard only when they are assembled, installed, adjusted, and tested 
according to instructions.  The assembler certifies that the system and its components were 
assembled, installed, adjusted, and tested according to the manufacturer's instructions.  Reliable 
certification, then, depends upon the manufacturer's providing adequate and complete instructions to 
the assembler. 
 
An x-ray system is an assemblage of components for the controlled production of x-rays.  The 
information disclosure obligation applies to each individually certified component produced by a 
manufacturer and is independent of the manufacturers decision to deliver a fully assembled x-ray 
system or subsystem.  The regulation establishes that manufacturers of certified components should 
provide to assemblers and others, upon request, AIAT information for the certified components of a 
diagnostic x-ray system. (21 CFR 1020.30(a)(1)) This means that AIAT information should exist 
for each certified component produced by a manufacturer and be available to others upon request. 
 
Explanation of Terms 
 
The agency would like to explain the meaning of four terms that comprise AIAT to help 
manufacturers and assemblers establish clear expectations about what information is subject to 
disclosure. 
 
  3  Contains Nonbinding Recommendations 
Assembly: To fit together the parts or pieces of a component or system.   
 
Discussion: New x-ray components and accessories are shipped to a final destination in various 
boxes and crates.  These components must be unpacked and properly assembled  before the unit 
can be used to make x-rays.  The typical major component of a diagnostic x-ray system cannot 
simply be removed from the box and used by the operator.  For example, various parts, such as 
printed circuit boards and switches, may require assembly into the control console of an x-ray 
control unit in a medical facility.  Assembly also includes the re-assembly of components that were 
not replaced but must be re-connected to the new component.  Correct electrical and hardware 
connections with all of the equipment must be made before using the system.  Such connections are 
considered assembly.  Complete assembly instructions in written form or software programs that 
automate the assembly process should be disclosed to the assembler to the extent they are part of 
the assembly procedures. 
 
Software programs may incorporate information that does not relate to assembly or re-assembly 
activities.  Such programs are not subject to disclosure.  For example, the consoles central 
processing unit may include unrevealed, protected software programs that create a log of assembly 
activities related to computer operations.  Should the manufacturer wish to check the assembly 
history on a particular system, this log would provide information, independent of the assemblers 
report, about when activities occurred and perhaps about the identity of the replaced components.  
This information does not fall within the scope of the AIAT disclosure requirements.   However, the 
incorporation of non-AIAT information or software does not change obligation of the manufacturer 
to release the required AIAT information.  It is incumbent upon the manufacturer to provide 
adequate AIAT information to the assembler. 
 
It is important to note that the term "assembly" and "installation" should not be used interchangeably.  
The term "installation" includes other activity not covered in the assembly activity. 
 
Installation: To set up for use by verifying that proper assembly and adjustments were made to 
assure compliance with federal performance specifications.   
 
Discussion: The unit should not be used on humans until the installation is completed in accordance 
with the manufacturers instructions, including any additional adjustments and testing needed to 
verify compliance with performance specifications.  For example, to complete the installation of an 
x-ray system, the assembler combines (or assembles) the various certified components, e.g., tube 
housing assembly, beam-limiting device, and x-ray control, into an interdependent operating system.  
The assembler should be sure that the components work in coordination with each other and do not 
cause any of the interdependent components to operate outside of the equipment manufacturer's 
specified tolerances or outside of applicable federal performance specifications, which are detailed 
in the regulations.  (21 CFR 1020.30 - 1020.33) 
 
The manufacturers documentation or software programs provide information on how the major 
components should be configured to meet applicable federal performance standards.  However, a 
manufacturer may also have software programs that operate with specifications that are narrower 
  4  Contains Nonbinding Recommendations 
than federal performance standards, which they use for internal quality assurance purposes.  In 
addition, the firm may have developed a particular sequencing of installation that operates in 
conjunction with system accessories that do not directly or indirectly impact electronic radiation 
emissions specifications.  This information does not fall within the scope of AIAT disclosure 
requirements. 
 
Adjustment: To bring various component parts up to a true or more effective relative position for 
performance purposes.   
 
Discussion: Adjustment covers activities performed on various components to make sure they work 
as a system within applicable federal performance standards.  For example, adjustments to the 
electrical circuitry are often needed to ensure the system does not operate outside of its 
performance specifications.  Calibration of the equipments operational parameters is achieved by 
adjusting the electrical or mechanical features of the component. 
 
The manufacturers documentation or software that provides adjustment information also serves a 
critical function so assemblers can ensure the component(s) will comply with the applicable 
performance standards.  Adjustment information would include any relevant calibration references.  
However, the manufacturer may have incorporated a proprietary software program that 
continuously monitors the performance of the system and alerts the manufacturer if the system may 
need adjustment in the future, even though it is currently operating within the performance standard.  
This information does not fall within the scope of AIAT disclosure requirements. 
 
Testing: A critical examination, observation, or evaluation of such conditions or operations through 
procedures provided by the manufacturer that will prove the unit meets specifications.   
 
Discussion: The regulations define the performance requirements for diagnostic radiographic 
exposure reproducibility such that the coefficient of variation of radiation exposures shall not exceed 
0.05.  (21 CFR 1020.31(b)(1))  A test method for determining compliance with this performance 
standard is identified in the regulations.  (21 CFR 1020.31(b)(2))  A test of x-ray equipment 
should produce data to verify the proper operation or performance of the x-ray system or 
component.  For example, information on how to test for radiation leakage or proper beam 
alignment is important when the assembler needs to use a special technique due to the special design 
of the component or when the beam alignment procedures are so complex that a computer program 
is needed. 
 
The manufacturers documentation or basic software programs provide critical information about 
testing for applicable federal performance standards that correspond to the manufacturer's AIAT 
specifications.  However, the manufacturer may have additional enhanced software programs, with 
privileged access codes, that conduct the required tests more quickly to save time.  The enhanced 
software programs may operate in conjunction with other proprietary accessories or functions, such 
as a daily test trend analysis that is relayed to the manufacturer in order to schedule advanced 
service calls.  This helps the user avoid any interruption in the clinical use of the system.  Such 
proprietary functions may increase the value of the system to the user, but the accessories and the 
  5  Contains Nonbinding Recommendations 
software programs used in conjunction with these functions do not fall within the scope of AIAT for 
purposes of meeting applicable federal performance standards, provided they are not required by 
the AIAT instructions. 
 
Manufacturers should provide all informational materials needed for assembly, installation, 
adjustment, and testing, as described above, regardless of the format in which those materials exist.  
Manufacturers may provide assemblers and other members of the public hard copies of instructional 
software, as long as the package made generally available contains adequate, complete, and useable 
instructions for assembly, installation, adjustment, and testing. 
 
Software 
 
Some manufacturers bundle AIAT information covered by 1020.30(g) with other types of 
proprietary software; in some instances the proprietary software cannot be deleted from the 
bundled information.  Nothing in section 1020.30 prohibits bundling software information or 
programs; however, the practice does not relieve manufacturers of their responsibilities under the 
performance standard to provide AIAT documentation or the AIAT software at cost.  
Manufacturers who bundle their AIAT software with other software may comply with 1020.30(g) 
by providing the entire bundle at the cost of the AIAT software.  Alternatively, the manufacturer 
may, by parceling the software domains, provide only the AIAT software to assemblers and others.  
Manufacturers may also satisfy the performance standard by providing printed materials, or by any 
other means that result in the provision of adequate, complete, and useable instructional materials. 
 
Cost 
 
Manufacturers may recover from assemblers and others the "cost" of providing required 
instructional materials.  Manufacturers should, in negotiation with purchasers, assemblers, and 
others, determine the dollar amount for any instructional package.  Although private parties can and 
should set the exact price for materials provided under subsection (g), the performance standard 
establishes limits on what costs manufacturers may recover in determining that price. 
 
The agency has explained that manufacturers may charge for the cost of producing each additional 
package or unit of instructions.  The charge can incorporate factors such as the cost of paper, labor, 
use of a copying machine, or other costs associated with each package the manufacturer provides 
under the performance standard.  This principle should govern the calculation of the costs for all 
information subject to disclosure, whether printed, encoded in software, or any other format.  For 
software, recoverable charges equivalent to printed materials would include such factors as the cost 
of the technical labor of producing such additional package or unit, computer disks, and packaging 
materials used to produce each additional unit of software.  Using a reasonable set of factors should 
govern the calculation of the costs for any materials that are provided. 
 
Although the question concerning cost has arisen primarily in the context of disclosing AIAT 
information, the same principle should also apply to the cost of disclosure of safety and technical 
information to the user of diagnostic x-ray systems or computed tomography equipment.  In any 
  6  Contains Nonbinding Recommendations 
scenario involving AIAT information disclosure, the factors that constitute a recoverable cost should 
not create a profit or loss for the manufacturer. 
 
Closing Summary 
 
The public health need to provide AIAT information to assemblers and users since the Radiation 
Control for Health and Safety Act was passed in 1968 has not changed.  If the information is not 
available, the public may be exposed to unnecessary radiation hazards from electronic products.  
Without this information, FDA, manufacturers, assemblers, users, and consumers could not make 
reasonable determinations or decisions associated with the safe and effective use of diagnostic x-ray 
systems and computed tomography components and systems in their health care. 
 
For further information regarding compliance with the information disclosure requirements for 
diagnostic x-ray systems and their major component systems, please contact Thomas M. Jakub at 
301 594-4591.  
 
  7