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NTAP/TPT Alternative Reimbursement Pathway Repealed for Breakthrough Devices – A Blow to Medical Device Innovation

By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting On Tuesday August 4, the Centers for Medicare & Medicaid Services (CMS) finalized the repeal of the alternative pathway for FDA-designated Breakthrough Devices to access the new technology add-on payment (NTAP) and transitional pass-through (TPT) programs. Over the past five years, the […]

  • September 13, 2026
News

FDA New Draft Guidance to expand the use of Pre-determined Change control Plans (PCCPs) from just AI/ML to now all medical devices

By Elle Winn, Mittal Consulting On August 22, 2024, the FDA released a new draft guidance discussing Predetermined Change Control Plans for Medical Devices. Predetermined change control plans (PCCPs) are FDA-authorized plans to implement changes to a medical device at a later point that are included in and approved in a marketing submission to the […]

  • August 21, 2024
News

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

This draft guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the reviews of 510(k) submissions and EUA requests by third party review organizations. This draft guidance provides updated recommendations on the 510(k) Third […]

  • December 12, 2023

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