US · guidance
CMS Pub. 100-02, ch. 14, § 20.3
FDA Withdrawal of IDE Approval or Change in Categorization
If the FDA becomes aware that a categorized device no longer meets certain
requirements and a sponsor (e.g., a manufacturer) loses its Category B status, or violates
relevant IDE requirements necessitating FDA’s withdrawal of IDE approval, all payment
for the device and related routine care items and services should cease. The CMS master
file and CMS Coverage Website will be updated to reflect withdrawals of FDA IDE
approvals and categorization changes, as appropriate.
History
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
923ddc2a9db9aa6a6dff961917345c627c4dac15d610d8faf7460fe7f9bfab75
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