Summary of the Electronic Product Radiation Control Provisions of the Federal Food, Drug, And Cosmetic (FD&C) Act

The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) are located in Sections 531 through 542 of the FD&C Act. The Radiation Control provisions apply to any "electronic product" which is defined as:

any manufactured or assembled product or article, which is intended for use as a component, part or accessory of such product, when in operation,

1. contains or acts as part of an electronic circuit and
2. emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.

In accordance with Section 531 (1) of the FD&C Act, "Electronic product radiation" is defined as:

1. any ionizing or non-ionizing electromagnetic or particulate radiation, or
2. any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

Examples of electronic products:

Medical: diagnostic x-ray or ultrasound imaging devices, microwave or ultrasound diathermy devices, microwave blood warmers or sterilizers, laser coagulators, ultrasound phacoemulsifiers, x-ray or electron accelerators, sunlamps, ultraviolet dental curing devices;

Non-medical: microwave ovens, televisions receivers and monitors (video displays), entertainment lasers, industrial x-ray systems, cordless and cellular telephones, industrial RF sealers of plastics and laminates, laser CD players.

SUMMARY OF PERFORMANCE STANDARDS

(Consult Regulations for full text)

The following are a few key elements of the performance standards for certain product types. Additional information can be found on the product specific summary webpages, in guidance, and in the regulations (21 CFR 1010 – 1050).

• applies to receivers and monitors that receive and convert a signal to display a "television picture" using a cathode ray tube
• limits radiation at 5 cm from the surface to 0.5 mR/hr during conditions of maximized user and service controls and a single worst-case component fault

• limits radiation at 30 cm to 10 mR/hr
• requires user precautions labeling

• applies to tube housings, generators and controls, film changers; fluoroscopic assemblies; spot film and image intensifiers; cephalometric devices; image receptor support devices for mammographic systems; diagnostic systems; CT systems (in part)
• limits leakage at 1 meter from the source to 100 mR in 1 hr and at 5 cm from any other components to 2 mR in 1 hr
• specifies beam limitations and beam quality criteria; user and assembler instructions and technical information

• requires control and indication of technique factors; timer termination conditions; accuracy and reproducibility specifications; indication and limits on field size and alignment, etc.
• limits transmission through mammographic image support system at 5 cm to 0.1 mR for each tube activation

• requires primary protective barrier; field limitation; continuous pressure control; source to skin distance; timer
• limits entrance exposure rates to 5 R/min (or 10 R/min with automatic exposure rate control)

• specifies user information on dose, imaging performance and quality assurance
• requires indication prior to initiation of scan, timer control to terminate or shutter the beam, indication of plane and alignment; beam on and shutter status indicators

• applies to systems with x-ray tube installed in an enclosure, including carry-on baggage inspection systems
• limits radiation at 5 cm to 0.5 mR/hr under maximized operating conditions and door positions; restricts human access to the primary beam
• requires 2 interlocks on each door with 1 resulting in physical disconnection of energy to the generator; key control; 2 independent x-ray on indicators; warning indicators and labels; user instructions, etc.

• applies to ovens for heating and cooking food (household or commercial; not industrial food processing)
• limits radiation at 5 cm to 1 mW per sq cm prior to purchase and 5 mW per sq cm throughout useful life under conditions of allowable door positions and primary interlock failure, or with conducting wire
• limits access by human body to energy-containing space and to 1 of 2 required interlocks; at least 1 interlock must be "monitored" to disable the source
• requires user caution label and user and service manuals

• applies to lasers, products containing lasers, and products intended to contain lasers
• specifies classification and user logotype with precautions based on radiation accessible during use; limits radiation from viewing optics, ports and displays to less than Class I; specifies interlocks/labels based on radiation accessible during maintenance and service
• requires, based on increasing hazard class, radiation indicators and safety: aperture label, beam attenuator, emission indicator (some with time delay), remote door interlock, key control, scanning safeguards, etc.
• requires user, maintenance and service manuals

• requires indication of power levels on medical lasers with +/- 20% accuracy
• limits radiation to less than Class IIIa for surveying, leveling and alignment lasers
• limits radiation to less than Class IIIa for demonstration lasers, including display or entertainment (NOTE: Variances, with extensive human access limitations, are often granted for laser light shows.)

• applies to products intended to produce skin tanning
• limits levels of UV-C radiation and ratio of UV-A/ UV-B; requires specification of compatible lamps
• requires maximum exposure time based on ultraviolet levels, timers with +/- 10% accuracy, protective eyewear, and user labeling and instructions

• requires self-extinguishing lamps to cease operating after breakage or removal of 3 sq. cm of the outer envelope
• specifies lamp packaging and advertisement information

SUMMARY OF REPORTING REQUIREMENTS

(Consult Regulations for full text)

Manufacturers of radiation emitting electronic products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005. A summary of the requirements for specific product types can be found in Table 1 of 21 CFR 1002.1.

21 CFR 1002.10, 11, 12. Product Reports (also Supplements, Abbreviated)

• applies to products listed in Table 1 of 1002.1 (most are subject to performance standards), unless excluded by 1002.1 or 1002.50
• documents information on manner of conformity to standards, labeling, test instrumentation, test procedures, quality control, etc.; submitted prior to family of products being introduced into commerce
• abbreviated reports were added in Oct 1995 to reduce burdens

• applies to products as listed in Table 1
• documents results of testing and user safety concerns; annually or quarterly updates contain model listings

• documents any actual or possible unexpected exposure during manufacturing, testing or use of ANY electronic product
• reports are due immediately after the event is known for occurrences where there is a death or injury (MDR may be substituted, if applicable) or otherwise as part of a summary on a quarterly basis

• applies to products not subject to performance standards and to products subject to standards if the standard does not address the specific safety issue
• exists, for products that USE radiation to accomplish the purpose of the product and emissions are intended, when radiation
  1. fails to meet design specifications, or
  2. is unnecessary and creates a risk of injury, or
  3. fails to accomplish its intended purpose
• exists, for products that DO NOT USE radiation to accomplish the purpose and do not intend to emit radiation, when radiation
  1. is emitted that creates a risk of injury, or
  2. fails to meet its design specifications

21 CFR 1003.10/.11. Determination of Noncompliance or Defect

• FDA or manufacturer informs the other of safety concern based on product testing, inspection, research, or review of reports or other data
• manufacturer notifies purchasers, dealers and distributors of the hazard and appropriate use until corrected (per 1003.21)

• applies to ALL radiation-emitting electronic products
• documents safety concerns, corrective actions, and information to users for safe use

21 CFR 1003.30 / .31. Exemption from Notification

• based on data to show there is no significant risk of injury as a result of the defect or failure to comply
• granted by FDA on own initiative or in response to written request from the manufacturer

21 CFR 1004.1 / .2 / .3. Repurchase, Repair, and Replacement

• correction of noncompliance or defect which is neither successfully refuted nor granted an exemption
• plan, including (draft) notification to users, documented by the responsible firm and approved by FDA (usually prior to implementation); may include one or more of the options to repair, replace or refund as needed

• Form FDA 2877 is filed by importer for entry (19 CFR 12.90)
• FDA samples and tests products to verify compliance if necessary
• products failing to meet applicable standards are refused entry by U.S. Customs

21 CFR 1005.21 / .22 / .23 / .24 / .25. Bringing Imported Products into Compliance

• under a U.S. Customs term bond, importer submits written application (usually Form FDA 766 ) for approval by FDA
• FDA supervises activities and the importer pays fees for such supervision

SUMMARY OF CERTIFICATION REQUIREMENTS

(Consult Regulations for full text)

21 CFR 1010.2 / .3. Certification and Identification Labels

• label(s) on each product subject to a standard identifying the name and address of the manufacturer and date of manufacture
• label on each product subject to a standard of the manufacturer's statement that the product complies with DHHS radiation standards or similar language

• manufacturers may request variances (i.e., an individual standard) for alternate, or equivalent, safety
• manufacturers may request exemption from a performance standard for reason of national security, investigations, etc.

SUMMARY OF COMPLIANCE ACTIONS FOR RADIATION CONTROL ACT VIOLATIONS

(Consult FD&C Act AND REGULATIONS for full text)

1. FDA Administrative Actions
   • Recall Products (corrective actions are approved and substantiated)
   • Disapprove Quality Control and Testing Program (i.e., embargo products)
   • Import Alert, Automatic Detention and Refusal (with U.S. Customs Service)
2. Actions through U.S. District Courts
   • Injunction from shipping in interstate commerce or to require reporting and certification requirements
   • Civil (money) penalties for failure to report, failure to certify, failure to comply with standards