Description
The Food and Drug Administration has information which indicates that some assemblers and manufacturers of diagnostic x-ray equipment are failing to notify FDA of radiation safety defects and noncompliances with performance standards discovered during the repair or installation of diagnostic x-ray systems. In addition, some owners of x-ray systems are being charged for correction of such defects or noncompliances where the law requires that these corrections be made at no cost to the owner.
Scope & Applicability
Product Classes
2Regulated product category for sunlamps
Obligations of Factory-based Manufacturers and Assemblers of Diagnostic X-ray Equipment
Stakeholders
3Person whose actions may cause a product to be deemed adulterated
Entity responsible for design or construction of x-ray components
Entity responsible for installing and testing diagnostic x-ray systems.; Person engaged in assembling, replacing, or installing components into a diagnostic x-ray system.; Person or entity responsible for installing and testing x-ray components.; Person or entity responsible for installing x-ray components; Individual or firm responsible for installing and reporting x-ray equipment
Related CFR Sections (1)
- 21CFR1003.2§ 1003.2 Defect in an electronic product.
For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if:Read full regulation →
See Also (8)
- Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff (Status: Final)
- Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) (Status: Final)
- Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) (Status: Final)
- Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11 (Status: Final)
- Product Recalls, Including Removals and Corrections: Guidance for Industry (Status: Final)
- CPG Sec. 396.300 Defective Suntanning Booths and Bed (Status: Final)
- Compliance Guide for Laser Products (FDA 86-8260) (Status: Final)
- Policy on Lamp Compatibility (sunlamps) (Status: Final)