US · guidance
CMS SOM App. H, Tag V383
§ 494.50(c)(2) – When clinically indicated (for example, after adverse patient reactions), the
facility must – (iii) Report the adverse outcomes to the FDA and other Federal, State or
local government agencies as required by law.
Page 169 of 420
Interpretive Guidance § 494.50(c)(2)(iii)
The dialyzer manufacturer may or may not be responsible for reporting adverse outcomes
related to reprocessing/reuse, depending on their legal liabilities. This regulation, however,
requires the facility to be responsible for reporting any adverse outcomes potentially related to
reprocessing/reuse, as required by law. Facility policy should address adverse occurrence
reporting.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
ad248e47ea007723aa8654c87d7ce78615c3d96f39d3a7ad0d63db30509e600a
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