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Introduction

We have received a number of questions concerning a manufacturer’s obligation under Federal law to disclose assembly information to third party servicers and others. An assembler or servicer needs the assembly information to reduce or control unnecessary radiation exposure. This letter reiterates information in earlier correspondence FDA sent to manufacturers and assemblers on December 24, 1997. Additional information is available on the Internet at the following Food and Drug Administration (FDA) Internet site: http://www.fda.gov/cdrh/comp/guidance/2619.pdf.

Background

Diagnostic x-ray components and systems are subject to the performance standards for ionizing radiation emitting products and to the medical device requirements of the Federal Food, Drug, and Cosmetic Act (the Act). (Sections 534 and 201(h)(2) of the Act)

Under the performance standards for ionizing radiation emitting products, manufacturers are subject to an information disclosure provision that covers instructions for the assembly, installation, adjustment, and testing (AIAT) of components that are part of a diagnostic x-ray system. Proper use of the assembly information will ensure that the system will comply with applicable performance requirements when the system is assembled, installed, adjusted, and tested according to the component manufacturers’ instructions. We have enclosed the text of the codified provisions that cover the AIAT information provisions. Please review the enclosure.

The disclosure of AIAT information does not exempt manufacturers from any labeling requirements that apply to medical devices in general, such as those contained in 21 CFR Part 801. Manufacturers should ensure that any information they provide is not false or misleading in any particular and provides sufficient information about the device for its intended use.

Scope of Disclosure Requirement

The parties affected by the AIAT information disclosure provision include equipment manufacturers of diagnostic x-ray components and systems; assemblers who install or replace one or more components into an x-ray system or a subsystem; and any interested party requesting AIAT information. The information subject to disclosure extends to any AIAT information that is necessary to assemble or install one or more components of a diagnostic x-ray system.

If special equipment or software is needed to comply with the AIAT provisions, the manufacturer should provide the equipment or software so the diagnostic x-ray system can meet federal performance requirements. When the manufacturer does not make the equipment or software available, the manufacturer should provide an adequate alternative means for installing the components into the system. Information, software, or equipment used for training, routine servicing, or maintenance falls outside the scope of the disclosure provision of 21 CFR 1020.30(g).

The cost of the information, software, or equipment that is needed to fulfill the AIAT information disclosure provision should not exceed the cost of copying, binding, producing, or distributing the AIAT materials. This means that the cost would exclude any charge for overhead and design development.

If you have questions about this letter or the referenced guidance document, please contact the Diagnostic Devices Branch at (301) 594-4591.

Sincerely yours,

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

Title 21 Code of Federal Regulations Part 1020 – PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

§ 1020.30 – Diagnostic x-ray systems and their major components.

Authority: 21 U.S.C. 351, 352, 360e-360j, 360gg—360ss, 371, 381.

Source: 38 Federal Register 28632, Oct. 15, 1973

(g) Information to be provided to assemblers. Manufacturers of components listed in paragraph (a)(1) of this section shall provide to assemblers subject to paragraph (d) of this section and, upon request, to others at a cost not to exceed the cost of publication and distribution, instructions for assembly, installation, adjustment, and testing of such components adequate to assure that the products will comply with applicable provisions of this section and Secs. 1020.31, 1020.32, and 1020.33, when assembled, installed, adjusted, and tested as directed. Such instructions shall include specifications of other components compatible with that to be installed when compliance of the system or subsystem depends on their compatibility. Such specifications may describe pertinent physical characteristics of the components and/or may list by manufacturer model number the components which are compatible. For x-ray controls and generators manufactured after
May 3, 1994, manufacturers shall provide:
(1) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;
(2) A statement of the maximum line current of the x-ray system based on the maximum input voltage and current characteristics of the tube housing assembly compatible with rated output voltage and rated output current characteristics of the x-ray control and associated high-voltage generator. If the rated input voltage and current characteristics of the tube housing assembly are not known by the manufacturer of the x-ray control and associated high-voltage generator, he shall provide necessary information to allow the assembler to determine the maximum line current for the particular tube housing assembly(ies);
(3) A statement of the technique factors that constitute the maximum line current condition described in paragraph (g)(2) of this section.

Link to 21CFR 1020.30

Updated Ocotber 16, 2003

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