US · guidance
CMS SOM App. C, Tag D5479
§493.1256 Standard: Control procedures
(e)(5) Follow the manufacturer’s specifications for using reagents, media, and
supplies and be responsible for results.
Interpretive Guidelines §493.1256(e)(5)
The laboratory must meet any and all regulatory requirements and comply with the
manufacturer’s requirements to the extent that the manufacturer’s requirements do not
conflict with any regulatory requirements. We encourage laboratories to also comply
with the manufacturer’s recommendations for testing to the extent that the manufacturer’s
recommendations do not conflict with any regulatory requirements.
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
864ad8563de310c23f9b6b899c7e7c0e5fe1ac9c1515d2fbbcf45bedbad5544a
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