US · guidance
CMS SOM App. D, Tag H0005
§486.100 - Condition for Coverage: Compliance with Federal, State,
and Local Laws and Regulations
The supplier of portable x-ray services is in conformity with all applicable Federal, State,
and local laws and regulations.
Interpretive Guidelines: §486.100
The supplier, its equipment and personnel must be licensed or registered in accordance
with applicable Federal, State, and local laws. Review licenses and registration permits
to confirm their validity and currency.
X-ray equipment manufactured on or after August 1, 1974, must bear a label indicating it
meets FDA standards. If equipment found in use is different from what was described to
the SA prior to survey, note the name of the manufacturer (if shown) so that this can be
checked out after the survey. Do not show a deficiency unless it has been definitely
ascertained that the equipment does not meet FDA Standards.
________________________________________________________________________
History
Rev. 28; Issued: 09-07-07; Effective/Implementation Date: 09-07-07
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
2fe7ce2f4431d5d6350b011bc03f0cf9fbb936adee11ce36deea487ef997dec9
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