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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 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.

This program applies to certain electronic products subject to radiation safety performance standards described in 21 CFR 1010 – 1040, including:

  • 21 CFR1020.10 Television Receivers
  • 21 CFR1020.40 Cabinet X-Ray Systems
  • 21 CFR1030.10 Microwave Ovens
  • 21 CFR1040.10 Lasers and Laser Systems
  • 21 CFR1040.11 Specific Purpose Laser Products
  • 21 CFR1040.20 Sunlamps and Sunlamp Products

Diagnostic x-ray inspection and testing is conducted under Compliance Program 7386.001. Products and manufacturers subject to standards contained in 21 CFR 1020 – 1050, but are not listed above, will be subject to inspection or test on a for-cause basis only at the direction of CDRH.

The body of this program contains basic instructions for inspection, field test and administrative/enforcement activities applicable to all electronic products. Inspection and field test checklists, and additional considerations and instructions for specific products, such as laser, sunlamp, cabinet x-ray, television and microwave oven products, are covered in ATTACHMENTS B – F.

Medical devices that emit electronic product radiation 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. Examples of radiation-emitting medical devices include medical laser and sunlamp products, which could be covered by a joint EPRC/medical device inspection.