FDA Withdrawal of IDE Approval or Change in Categorization

20.3 - FDA Withdrawal of IDE Approval or Change in Categorization (Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15) 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.