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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 II: Program / Implementation

PART II - PROGRAM / IMPLEMENTATION

  1. Objectives

    This is a continuing, non-statistical compliance program intended:

    1. To evaluate an electronic product manufacturer's quality control testing program for its ability to ensure such product compliance and radiation safety.
    2. To identify certified electronic products which fail to comply with the requirements of applicable performance standards
    3. To obtain correction of deficient quality control testing programs and noncompliant products identified by initiating appropriate administrative/regulatory action.
    4. To provide guidance to manufacturers regarding compliance with the laws and regulations administered by FDA.
  2. Program Management Instructions

    1. Planning Instructions

      1. The role of the individual investigator and field radiological health specialists is a critical factor for the effective implementation of this program. Field specialists such as Electro- Optics Specialists (EOS) and Regional Radiological Health Representatives have been specifically trained in general EPRC requirements and may have specialized training in one or more performance standards.

        Only individuals trained in EPRC requirements should perform these inspections and field tests. Contact CDRH/OCER Electronic Products Branch (HFZ-240) and DFI (HFC- 130) should the need for expertise, not otherwise available in the District, become apparent. At the discretion of CDRH and the district, radiological health specialists may be used to accompany a medical device investigator to conduct joint EPRC/medical device inspections. If an individual has training in both EPRC and medical device inspections, a single individual may conduct both portions of the inspection.

      2. Field radiological health specialists, their particular area of expertise, physical location and primary geographical areas of responsibility are listed in Part VI of this program.

      3. Based on the resources in the current FY workplan, field radiological health specialists will develop assignments for their organization. The assignments will be reviewed by his or her supervisor, entered into FACTS and transmitted to the affected field staff, Districts, HFC-l32 and HFZ-240. Workplans should include district inspections, field tests, and known CDRH assignments. The establishment inventory and guidance from CDRH should be used to determine inspection and field test locations.

    2. Pre-announcement of Inspections

      Pre-announcement of EPRC inspections conducted under this compliance program is not mandatory, although it is recommended to facilitate the inspection. Pre-announcement ensures the firm is producing electronic products for the US market on the day of inspection, gives the firm time to collect all necessary procedures and records, and ensures appropriate individuals are available during the inspection. Section 537 of the Act permits inspection of any manufacturer for good cause, grounds for which may include introduction of any noncompliant product into US commerce, failure to comply with EPRC reporting requirements, or for purposes of suspected problems with a manufacturer's quality control testing program and product conformance with performance standards.

      Inspections of radiation-emitting medical device manufacturers must be pre-announced if the inspection will cover medical device Quality Systems Regulation compliance. Refer to instructions provided in the Guide to Inspections of Quality Systems, August 1999, and IOM Section 5.2.1.1, Pre-Announcements.

    3. Pre-announcement of Field Tests

      Schedule an appointment with the user prior to the field test. Tell the user that the purpose of the visit is to conduct a survey of an electronic product to determine compliance with FDA's Federal radiation safety performance standards.

      Request that persons familiar with the operation of the electronic product to be tested be available to assist in the operation of the equipment.

    4. Inspections and Field Test Priorities

      Inspections and field testing of electronic product manufacturers should be prioritized using the following criteria:

      1. Manufacturers and products posing a potential risk to public health or with great public health impact. High-risk products may be identified by additional product-specific guidance provided in Attachments B – F, direction provided from CDRH, level of radiation emissions accessible to the public or volume of products on the US market.
      2. Manufacturers or products with known compliance problems discovered through field testing, report review, complaints or other reason.
      3. New manufacturers that have not yet been inspected
      4. Products incorporating technology new to the US market or a major change in existing product.
    5. Resource Instructions

      1. Field personnel may require personal radiation monitors, such as thermal luminescent dosimeter badges, when performing tests under this program. Dosimeters must be worn when performing inspections of cabinet x-ray manufacturers, cabinet x-ray field tests, and other products that can emit x radiation. These monitors are available from the Winchester Engineering and Analytical Center (WEAC) Radiation Safety Officer. Part VI of this program contains the current list of contacts for WEAC.

      2. Field personnel are responsible for contacting OCER and OSEL to arrange to have their radiation measurement equipment re-calibrated annually. Any personnel that do not have the appropriate radiation meters may request that equipment be loaned by another district or by CDRH, if available.

        CDRH will be phasing out calibration services currently provided for a number of instruments in the field, and alternate sources of equipment maintenance and calibration services will be identified. CDRH will assist in identifying sources for these services, and will maintain an inventory of equipment that may be available for use by field staff on loan.