Description
The Office of Compliance, Center for Devices and Radiological Health (CDRH) developed this guide.This guidewill assist manufacturers of electronic products which emit radiation in providing adequate reporting of radiation safety testing and compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify Reporting and Notification requirements.
Scope & Applicability
Product Classes
5An x-ray system with the x-ray tube installed in an enclosure
Specific product type under cabinet x-ray systems
Specific product type under cabinet x-ray systems
Specific product type under cabinet x-ray systems
Baggage inspection devices used in public facilities
Stakeholders
4Entity responsible for submitting NDINs
Person whose actions may cause a product to be deemed adulterated
The entity that may provide the support surface for the system floor.
Must comply with registration if meeting facility/responsible person definitions
Regulatory Context
Attributes
9Technical characteristic of the x-ray system
Quotient of dQ by dm regarding ions produced in air
Calculated as pulses per burst multiplied by bursts per second
Produced by specific tube potential, current, and beam orientation
Technical characteristic of the x-ray system
Statement regarding the state of the key during operation.
Required label showing compliance certification.
Identification element for the system.
Production identifier element
Identified Hazards
Hazards
7Determination made by CDRH regarding product safety
Radiation at the external surface of the cabinet
Location of maximum intensity must be determined during testing
The release of x-rays that must be limited and measured for compliance.
A condition that must be analyzed to see if it results in unintended x-ray generation.; Accidental electrical grounding
Failure that could impact the safety interlock system.
Safety concern affected by service adjustments
Related CFR Sections (3)
- 21CFR1020.40§ 1020.40 Cabinet x-ray systems.
(a) Applicability. The provisions of this section are applicable to cabinet x-ray systems manufactured or assembled on or after April 10, 1975, except that the provisions as applied to x-ray systems designed primarily for the inspection of carry-on baggage are applicable to such systems manufacturedRead full regulation →
- 21CFR1002.7§ 1002.7 Submission of data and reports.
All submissions such as reports, test data, product descriptions, and other information required by this part, or voluntarily submitted to the Director, Center for Devices and Radiological Health, shall be filed with the number of copies as prescribed by the Director, Center for Devices and RadiologRead full regulation →
- 21CFR1002.20§ 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, report to the Director, Center for Devices and Radiological Health, all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from theRead full regulation →
See Also (8)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff (Status: Final)
- Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (Status: Final)
- Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (Status: Final)
- Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) : (Status: Final)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)