Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 102030, 102031, 102032, 102033); Small Entity Compliance Guide
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
February 21, 2023
February 21, 2023
25da0cdb-88f7-4421-adc2-fac6f5f588fa
Related Documents
Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff
Guidance DocumentAugust 19, 2024Center for Devices and Radiological Health
Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentFebruary 21, 2023Center for Devices and Radiological Health
Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff
Guidance DocumentJune 25, 2024Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox