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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 III: Inspectional

PART III - INSPECTIONAL

  1. Operations

    1. Inspectional Strategy

      The purpose of electronic product manufacturer inspections is to evaluate the firm's quality control testing program to ensure product compliance with applicable performance standards and radiation safety. The inspection should also verify that EPRC requirements for reporting and recordkeeping are met by the firm.

    2. Electronic Product Radiation Control Inspection

      Review the firm's quality control testing program required under 21 CFR 1010.2 to ensure product compliance with the x-ray performance standards in 21 CFR 1020. These items may be reviewed in conjunction with review of QSIT elements when a joint EPRC/medical device inspection is conducted. The firm's quality control testing program ensuring compliance with the x-ray performance standard will be integrated throughout the firm's quality system required by 21 CFR 820.

      Each manufacturer of a certifiable x-ray system or component is required to submit a radiation safety report for its specific product to CDRH prior to introducing products into commerce. Using the appropriate guide for the product under investigation and the general instructions from Chapter 5 of the IOM, the investigator will inspect pertinent records and files of the firm covering each of the following.

      1. Items to cover

        1. The firm's product(s) comply with the applicable requirements of the standard to the extent that:

          • The product has the applicable performance features, labels, and instructions for operation, maintenance and service
          • The product emissions are properly characterized.
          • The brochures, catalogs and other promotional material contain any required warnings or label reproductions
        2. The firm has procedures and documents for control of the manufacturing process appropriate to the product type and production volume including:

          • Stock and inventory control
          • Bills of materials
          • Control drawings and procedures that are authenticated and current
          • Incoming inspection, criteria for acceptance/rejection, and segregation of accepted from rejected parts
          • Disposition of rejected parts
          • Finished goods storage and inventory
        3. The firm has adequate quality control testing procedures and records to demonstrate:

          • Production testing performed at the firm as described in the report submitted to CDRH
          • In-production tests to verify product compliance during production
          • Final test and inspection of finished products
          • Maintenance and calibration of test equipment
          • QC/QA activities are contained in and reported to management organization other than the organization responsible for design and production
        4. The firm maintains records required by the electronic product radiation control regulations:

          • Distribution to first purchasers or distributors (note: dealers and distributors of certifiable products valued at $50 or above are required to maintain detailed distribution records of the product(s). The distributor/dealer has the option to retain those records or to forward them to the original manufacturer. Determine if the manufacturer is receiving such records and if so, is maintaining them in a retrievable manner.)
          • Test results and data supporting product compliance with FDA performance standards
          • Safety related complaints, inquiries
          • Real or alleged injuries
          • Remedial actions taken for reports of non-compliant products, complaints, injuries
          • Reports submitted to CDRH
      2. Records to collect

        1. Organization chart identifying key individuals responsible for product design, manufacturing and quality control
        2. Copies of testing procedures and where possible photographic evidence showing that testing does not ensure product safety or compliance with applicable standards
        3. Samples of violative labels
        4. Copies of manuals, in part or whole, that fail to contain required materials
        5. Copies of brochures and catalogs that fail to contain required warning or label reproductions
        6. Distribution records for any violative products
      3. Foreign inspections

        All foreign inspections should be conducted using this guide, and any special instructions contained in the inspection assignment. The failure of any foreign manufacturer to comply with these requirements may result in the article being refused admission into the United States.

        Foreign inspections are subject to scheduling and time constraints as several manufacturers will be inspected in a single trip. Early planning is critical to conducting foreign inspections. Firms inspected must be notified as early as possible to ensure the firm will be producing for the US on the day of inspection, to give the firm time to collect all necessary procedures and records, prepare translations of needed documents, and make arrangements to have a translator available if needed.

        Any investigator with appropriate training may conduct foreign EPRC or joint EPRC/medical device inspections.

      4. Medical Device Inspections

        Radiation-emitting medical devices are subject to both electronic product radiation control requirements and medical device requirements including the Quality System, Medical Device Reporting (MDR), Medical device Tracking, Corrections and Removal, and Registration and Listing regulations.

        Based on district concurrence, a joint EPRC/medical device inspection covering the firm's compliance with both sets of requirements may be conducted under this compliance program and Compliance Program 7382.845 for Inspection of Medical Device Manufacturers.

        • The EPRC portion of the inspection should follow the instructions provided specifically in this program to determine the firm's compliance with electronic product radiation control requirements for reporting and recordkeeping, certification to applicable performance standards, and a quality control testing program that ensures product compliance and radiation safety. Report EPRC time under the appropriate PAC identified in this program.
        • The medical device portion of the inspection should follow instructions provided in the medical device inspection compliance program to assess the firm's quality system. Manufacturers of devices subject to the diagnostic x-ray radiation safety performance standards contained in 21 CFR Parts 1020.30 – 1020.33 should include in their device master and history records those procedures and records demonstrating compliance with the applicable standard, self-certification (21 CFR 1010), and reporting (21CFR 1002 – 1005). Report medical device time under the appropriate medical device PAC identified in Compliance Program 7382.845.
      5. For-Cause Directed inspections

        For-cause inspections are conducted in response to specific information that raises questions, concerns, or problems associated with the electronic product. Information can come from a variety of sources including:

        • Sample analysis results
        • Prior inspectional observations
        • Questionable information in product reports
        • Reports of injuries related to the firm's products
        • Consumer or trade complaints about the firm.

        For cause inspections are usually initiated at the request of CDRH. For-cause inspections will generally follow instructions provided in this compliance program, and additional instructions or issues will be provided in the assignment.

      6. Inspectional Observations Review

        Review inspectional observations with the most responsible individual and other technical experts at the firm prior to concluding the inspection. Record EPRC observations on the Form FDA-483. This compliance program provides guidance concerning severity of violations observed to identify major deficiencies. Deficiencies should be noted on Form FDA-483 in order of descending importance (i.e. most serious first). If both EPRC and medical device observations are noted, they should be grouped separately on the form.

        The district has discretion to offer annotation of the FDA 483 for an EPRC inspection, if the investigator and firm believe annotation will facilitate the inspection process. An offer to annotate the FDA 483 should be extended for all joint EPRC/medical device inspections. When a FDA 483 is annotated, it should be done in accordance with the IOM Chapter 5 (Section 5.2.3).

        The following statement should be included on each FDA 483:

        "This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective actions in response to an observation, you may discuss the objection or action with FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above."

        For all medical device inspections the FDA 483 should contain the following additional statement:

        "The observations noted in this form FDA 483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self audits to identify and correct any and all violations of the quality system requirements."
    3. Investigations

      Investigations are to be made to determine whether a suspected firm is in fact a manufacturer of one or more electronic products. The investigation may be initiated in preparation for a possible inspection, as a result of trade complaints, or from discovery via the Internet or printed materials of promotion of products that may not comply with EPRC requirements.

    4. Physical and Documentary Samples

      Under this program, physical samples will be collected only upon CDRH approval or under special request from CDRH. Documentary samples will be collected as necessary to document conditions of noncompliance and violations of EPRC standards.

Collect samples according to procedures defined in the Investigations Operations Manual, Chapter 4, and coordinate any sample collection activity with CDRH or WEAC to ensure proper procedures are followed and chain of custody is observed to maintain sample integrity.