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Summary Of The Electronic Product Radiation Control Provisions Of The Federal Food, Drug, And Cosmetic Act |
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The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) are located in Sections 531 through 542 of the Act. They apply to any "electronic product" which is defined as:
any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation,
(i) contains or acts as part of an electronic circuit and
(ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.
"Electronic product radiation" is defined as:
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) 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.
21 CFR 1020.10. Television Receivers
applies to receivers and monitors that receive and convert a signal to display a "television picture"
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
21 CFR 1020.20. Cold-cathode Discharge Tubes
limits radiation at 30 cm to 10 mR/hr
requires user precautions labeling
21 CFR 1020.30. Diagnostic X-Ray Systems and their Major Components
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
21 CFR 1020.31. Radiographic Equipment
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
21 CFR 1020.32. Fluoroscopic Equipment
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)
21 CFR 1020.33. Computed Tomography (CT) Equipment
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
21 CFR 1020.40. Cabinet X-Ray Systems
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.
21 CFR 1030.10. Microwave Ovens
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
21 CFR 1040.10. Lasers and Laser Systems
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
21 CFR 1040.11. Specific Laser Products
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.)
21 CFR 1040.20. Sunlamps and Sunlamp Products
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
21 CFR 1040.30. High-intensity Mercury Vapor Discharge Lamps
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
21 CFR 1050.10. Ultrasonic Therapy Products
applies to applicators or generators operating above 16 kHz for physical therapy
provides indication of radiation parameters: average and temporal peak power and/or intensity; pulse duration, pulse repetition rate; effective radiating area; beam nonuniformity and spatial distributions, etc.
requires power accuracy of +/- 20% and timer accuracy +/- 10%
21 CFR 1010.4, 1010.5. Variances; Exemptions
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.
21 CFR 1002.20. Accidental Radiation Occurrences
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 (MDR may be substituted, if applicable)
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
21 CFR 1002.13. Annual Reports
applies to products as listed in Table 1
documents results of testing and user safety concerns; annually or quarterly updates contain model listings
21 CFR 1003.20. Notice of Defect or Noncompliance
applies to ALL radiation-emitting electronic products
documents safety concerns, corrective actions, and information to users for safe use
21 CFR 1003.2. Defect in an Electronic Product
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)
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
21 CFR 1005.3/.10. Importation Requirements
Form FDA 2877 is filed by importer for entry (19 CFR 12.90)
FDA samples and tests products to verify compliance if necesarry
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
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
A. 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)
B. 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
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