US CMS Newsroom · August 07, 2026

Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487-NC) Procedural Notice Inviting Comment

CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.

Medium impact Medical Devices & IVD Market Access & Reimbursement United States Medical devicesReimbursementMarket surveillance

Fact Sheets Aug 07, 2026 Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487-NC) Procedural Notice Inviting Comment Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487-NC) Procedural Notice Inviting Comment The Centers for Medicare & Medicaid Services (CMS) issued a proposed procedural notice outlining a faster way for manufacturers to get new devices covered by Medicare: the Read more about Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487-NC) Procedural Notice Inviting Comment

Dates and deadlines

Regulatory Deadline

August 07, 2026

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