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  4. Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide
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GUIDANCE DOCUMENT

Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide February 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2001-N-0178
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2001-N-0178.

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