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U.S. Department of Health and Human Services

Medical Devices

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Inspection and Field Testing of Radiation-Emitting Electronic Products - 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

      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. If appropriate, request to make measurements during the inspection using available FDA or manufacturer instruments to confirm emission specifications are below any established limits. Otherwise, witness the measurements performed by the manufacturer to confirm.
          • 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 quality control testing procedures and records to cover:

          • In-production tests to verify product compliance during production
          • Final test and inspection of finished products
          • Maintenance and calibration of test equipment
        4. The firm maintains records required by the electronic product radiation control regulations:

          • Distribution to first purchasers or distributors
          • Safety related complaints, inquiries
          • Real or alleged injuries
          • Remedial actions taken for reports of non-compliant products, complaints, injuries
          • Reports submitted to CDRH

            Specific product inspection and field test checklists or forms, if available, are included in ATTACHMENTS B – F. These checklists should be used in conjunction with the above guidance to record inspection and test observations.

      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. Distribution records for any violative products

        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 detention upon entry.

        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. For example, field specialists such as Electro Optics Specialists (EOS) and Regional Radiological Health Representatives have been trained in general EPRC requirements and may have specialized training in one or more performance standards.

      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 radiation safety performance standards contained in 21 CFR Parts 1020 – 1050 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, with additional questions and issues to cover 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. Electronic Product Radiation Control Field Tests

      Field tests are examinations of installed electronic products and may be conducted at trade shows, manufacturing facilities or other sites where products are in use. Field tests assess the individual product's compliance with applicable performance standard requirements alone. It can not be expected that there will be staff on site with expert knowledge of the product being field tested or that it will be possible to evaluate all aspects of product compliance.

      1. Items to cover:

        1. Product emissions are properly characterized. If possible, confirm by direct measurement using FDA or available instrumentation on-site documenting all maintenance and calibration information. At a minimum, document claimed product emissions based on product labeling review.
        2. Product incorporates required performance features
        3. Product displays the labels with required contents

        If the product becomes damaged during a field test, the owner, investigator, and supervisor should complete the appropriate sections of the form FDA 2766 entitled, Claim for Damages to an Electronic Product. Instructions for completion are on the back of the form, which is available from the FDA Forms Catalog (see FDA intranet home page under "forms" section).

      2. Records to collect:

        1. Purchase information documenting the manufacturer and distributor of the product
        2. Supporting documents or photographic evidence for questionable items, including noncompliant user and service manuals, inadequate protective housing, lack of interlocks, or lack of required labeling
        3. Copy of promotional literature to show product specifications and intended use
        4. Samples of violative labels
        5. Copies of manuals (or manual sections) that fail to contain required materials
      3. Field test observations review

        Review field test observations with the most responsible individual at the location and with other appropriate staff after completing the field test. Deficiencies should be noted in order of descending importance (i.e. most serious first) on the field test record form. If a field test is conducted as part of an inspection, field test results should be noted on the FDA-483 along with inspectional observations.

        Share observations by providing a copy of the FDA- 483 and/or field test checklist or form.

        Indicate that FDA will follow up with the manufacturer and take action to correct deficiencies, as appropriate. In the event of a Class A hazard, recommend the product should not be used until corrected. This compliance program provides guidance concerning severity of violations observed to identify major deficiencies in ATTACHMENTS A – F.

    4. 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.

    5. Physical and Documentary Samples

      Physical samples of products are generally not collected under this compliance program. Samples are not required to support a letter issued to the firm or further action to include program disapproval or legal action. However, samples can be useful to support inspectional observations to demonstrate inadequacy of the quality control testing program or product noncompliance. The investigator should consult district management and CDRH to determine whether collecting physical samples would support any subsequent letter or action initiated. Documentary samples may be collected when collecting an actual physical sample is not practical and the evidence is necessary to support inspectional observations.

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