Description
This compliance policy guide provides FDA’s policy on electronic products that fail to comply or has a defect under 21 CFR 1003.11.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Additional recommended information for Electronic Product notifications
Stakeholders
2The Secretary has sole discretion to refund fees
Entity responsible for submitting NDINs
Technical Details
Processes
3The process of installing and adjusting diagnostic x-ray components at a user location.
Manufacturer responsibility for defects resulting from production
Manufacturer responsibility for defects resulting from design
Identified Hazards
Hazards
2Radiation emitted by electronic products that requires control
Nonconformity in the device
Standards & References
Specifications
1Applicable standards for electronic products
Related CFR Sections (1)
- 21CFR1003.11§ 1003.11 Determination by Secretary that product fails to comply or has a defect.
(a) If, the Secretary, through testing, inspection, research, or examination of reports or other data, determines that any electronic product does not comply with an applicable Federal standard issued pursuant to the Act or has a defect, he shall immediately notify the manufacturer of the product inRead full regulation →
See Also (8)
- CPG Sec. 398.375 Obligations of Factory-based Manufacturers and Assemblers of Diagnostic X-ray Equipment Under the Performance Standard for Diagnostic X-ray Equipment (Status: Final)
- 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)
- 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)
- CPG Sec. 398.325 Regulatory Actions Against Assemblers Noncompliant Diagnostic X-Ray Equipment (Status: Final)