Description
Analysis of Field testing performed on certified medical x-ray systems and components has indicated an unacceptable rate of failure to comply with the Diagnostic X-ray Standard. Most of these noncompliances result from assemblers who have failed to properly follow manufacturers' assembly instructions. Stricter enforcement to assure the proper assembly of diagnostic x-ray equipment is therefore expected to have an overall effect of reducing the rate of noncompliance.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Guidance for manufacturers of diagnostic x-ray equipment regarding radiation control regulations.; Subject of the radiation control regulations; Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment; General category of equipment covered by the guidance; subject of the radiation control regulations
Stakeholders
1responsibilities provided in FDA's guidance regarding installation; Personnel who install equipment and must follow manufacturer instructions.; Reports installation of diagnostic x-ray systems; Defined as any person engaged in the business of assembling, replacing, or installing components into a diagnostic x-ray system.; Person who installs, adjusts, and tests equipment
Regulatory Context
Document Types
1Field Compliance Testing of Diagnostic Medical X-ray Equipment
Attributes
2Field test results are classified as either Class A or Class B noncompliances
Field test results are classified as either Class A or Class B noncompliances
Standards & References
External Standards
1failure to comply with the Diagnostic X-ray Standard
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 (4)
- Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) (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)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (Status: Final)