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U.S. Department of Health and Human Services

Medical Devices

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Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment - Part I: Background

PART I - BACKGROUND

This compliance program provides guidance to FDA field and center staff for the inspection, field test and administrative/enforcement activities related to the Electronic Product Radiation Control (EPRC) provisions of the Federal Food Drug and Cosmetic Act (FFDCA, the Act) and regulations contained in Title 21 of the Code of Federal Regulations, Parts 1000 – 1050 (21 CFR 1000 – 1050). The intent of these requirements is to protect the public from unnecessary exposure to electronic products radiation. Manufacturers are responsible for producing products that do not emit hazardous or unnecessary radiation and that comply with all applicable radiation safety performance standards. All electronic product manufacturers must comply with applicable requirements in Title 21 CFR 1000, 1002, 1003, 1004 and 1005. If a mandatory radiation safety performance standard applies to a manufacturer’s product, then the manufacturer must also comply with Title 21 CFR 1010 and the product must comply with the requirements of the specific standard found in 21 CFR 1020 – 1050. Manufacturers are required to self-certify their own products to be compliant with an applicable standard, based on a quality control testing program as described in 21 CFR 1010.2. The purpose of EPRC inspections and field tests are to verify that products comply with performance standards, and that the manufacturer’s quality control testing program ensures such product compliance and radiation safety.

The Food and Drug Administration (FDA) is authorized to “review and evaluate” testing programs carried out by the industry to assure that the products minimize the delivery of unnecessary radiation to patients and to meet the standards issued regarding such products. Manufacturer compliance has been monitored through several mechanisms. The Center for Devices and Radiological Health (CDRH) and/or FDA’s Office of Regulatory Affairs (ORA) reviews and evaluates manufacturer radiation safety reports, conducts field tests of products that have been installed and are in use, conducts laboratory testing of selected products, and inspects manufacturer sites to assess the adequacy of the QC testing and record keeping programs established by the manufacturer.

The focus of this compliance program will be the investigation and inspection of those x-ray products that have been designed and manufactured for use in the diagnostic medical irradiation of humans. The specific performance standards for diagnostic x-ray systems and their major components are contained in 21 CFR 1020.30 through 1020.33. Firms covered under this program may produce either complete systems or individual components that are designed to be compatible with components produced by other manufacturers and assembled into a completed system at the final user location. Since manufacturers of such x-ray components may not produce complete systems, inspections under this program can be complex. Because of this complexity, investigators conducting inspections under this program must have in-depth knowledge of the EPRC provisions of the FFDCA and familiarity with radiation measurement techniques and instrumentation in addition to an understanding of medical device quality control processes. Training programs will be conducted by CDRH and ORA on an as-needed basis to assure that a sufficient number of properly qualified field personnel are available to meet the needs of the program.

Medical devices that emit electronic product radiation, such as diagnostic x-ray systems and components, are subject to EPRC requirements as well as Medical Device provisions of the Act and related regulations.

Medical device inspection and enforcement activities described in Compliance Program 7382.845, Inspection of Medical Device Manufacturers, may be conducted jointly with this program at CDRH and district discretion.

The EPRC provisions of the FFDCA mandate self-certification by manufacturers that their products meet the requirement of the regulations. Each manufacturer must determine the applicable requirements of the regulations and institute a program that assures the performance of their product. Prior to introduction into commerce, manufacturers are required to report this information to CDRH and properly label their products. To aid in this process, CDRH has published guidance in the form of reporting guides. The focus of these guides is to identify the pertinent information required for the specified certifiable components and to present an outline for a manufacturer to follow in preparing required information for certifiable components subject to the EPRC Performance Standards under 21 CFR 1020.30, 1020.31, and 1020.32. The reporting guides represent a mapping of the evaluation and self-certification of the conformance of diagnostic x-ray components to the applicable EPRC regulations. The guides have been created as a step-by-step process to lead manufacturers through the regulations and outline an acceptable format to establish and document programs leading to compliance for each type of regulated product.

There are currently three active guides available;

  1. "A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components",
  2. "A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems.", and
  3. "A Guide for the Submission of an Abbreviated Initial Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use"

The abbreviated guide recognizes that the requirements for the covered products focus on limited sections of the general guide and provides a less complex report for these products. It should be noted that it is acceptable for the manufacturers of these components to use the full format guide and many have done so. These references may aid investigators in preparing for and conducting diagnostic x-ray manufacturer inspections.