Radiation Controls

• Emission (or leakage) limits; time and spatial limits
• Means to terminate radiation, such as beam blocks or off switches
• Timers and controls for setting radiation parameters - including accuracy specifications
• Means to indicate when/how much radiation is emitted
• Interlocks and spatial limitations to prevent human access to radiation areas
• Shields and doors to contain radiation
• Failure modes and factors affecting increased radiation with age or use of the product
• Definitions of technical terms

Testing

• Radiation parameters to be measured
• Instrumentation specifications
• Measurement conditions, such as time, distance, medium, etc.
• Specifications on accuracy, reproducibility, linearity, and/or variance

Labeling

• Warning labels
• Precaution labels; use labels
• Radiation specification labels (from measurements)
• User manuals: dose/exposure rate information; safe use instructions; precautions
• Service manuals: safety instructions for installation, replacements (and compatibility), maintenance, service
• Certification and identification labels

Summary of Specific Performance Standards

• 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

• Applies to ovens for heating and cooking food (household or commercial; not industrial food processing)
• Limits radiation at 5 cm to 1 mW per cm² prior to purchase and 5 mW per cm² 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.)

Variances; Exemptions, 21 CFR 1010.4, 1010.5

• 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.

Accidental Radiation Occurrences, 21 CFR 1002.20

• 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)

Product Reports (also Supplements, Abbreviated), 21 CFR 1002.10 – 1002.12

• 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

Annual Reports, 21 CFR 1002.13

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

Notice of Defect or Noncompliance, 21 CFR 1003.20

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

Certification and Identification Labels, 21 CFR 1010.2 – 1010.3

• Label(s) on each product that is 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

Defect in an Electronic Product, 21 CFR 1003.2

• 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
• Fails to meet design specifications, or
• Is unnecessary and creates a risk of injury, or
• 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
• Is emitted that creates a risk of injury, or
• Fails to meet its design specifications

Determination of Noncompliance or Defect, 21 CFR 1003.10 – 1003.11

• 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)

Exemption from Notification, 21 CFR 1003.30 – 1003.31

• 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

Repurchase, Repair, and Replacement, 21 CFR 1004.1 – 1004.3

• 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

Importation Requirements, 21 CFR 1005.3 – 1005.10

• 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

Bringing Imported Products into Compliance, 21 CFR 1005.21 – 1005.25

• 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

FDA Administrative Actions, 21 CFR 1004.6, 1010.2(c), 1005.3

• 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)

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