Issue Date: February 21, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Radiology
Status: Final
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide
On June 10, 2005, the Food and Drug Administration (FDA) published a final rule entitled “Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components” (70 FR 33997; subsequently referred to as “the rule”), which amended the performance standard for diagnostic x-ray systems and their major components. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28) to assist small entities to comply with these changes in the performance standard, which became effective June 10, 2006. A subsequent amendment to the Radiological Health Regulations (88 FR 3638; January 20, 2023), removed certain reporting requirements for diagnostic x-ray systems and their major components and the current version of this guidance reflects these changes.
Download the Guidance Document
