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The RAPID Coverage Pathway: FDA and CMS Move in Step for Breakthrough Devices
ALTAQ INSIGHTS | REGULATORY AFFAIRS and REIMBURSEMENT What the new same-day coverage process offers device makers, and how the procedure actually works from pre-IDE to National Coverage Determination For years, the hardest part of bringing a Breakthrough Device to Medicare patients has not been the FDA review. It has been what comes after. A device could earn market authorization and then wait a year or more for a Medicare coverage decision, often while the sponsor generated
Fayyaz Memon
Sep 236 min read
Navigating the New York State CLEP Program to Achieve Approvals
The Clinical Laboratory Evaluation Program (CLEP) , overseen by the New York State Department of Health’s Wadsworth Center, is a...
Fayyaz Memon
Sep 25, 20252 min read
QMSR vs. QSR: What’s Changing and How AltaQ Can Help You Make the Transition in Time for 2026
Final Rule: The FDA has finalized a major final rule to amend device current good manufacturing practice requirements of the Quality...
Ivana Loffa
Aug 25, 20252 min read
The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions
The FDA issued draft guidance for PCCP for AI-enabled devices on April 3, 2023, followed by draft guidance for PCCP for all medical...
Zain Memon
Feb 5, 20252 min read
The FDA LDT Final Rule and SCOTUS ruling on the Chevron Doctrine - What is next?
On Jun 28, 2024, SCOTUS overturned the Chevron doctrine, which means that courts will no longer automatically defer to agency expertise...
Fayyaz Memon
Jul 31, 20242 min read
The FDA's LDT Rule Explained
The FDA’s LDT regulations have been long in the making since the release of draft guidance, “Draft Guidance for Industry, Food and Drug...
Fayyaz Memon
Jul 16, 20243 min read
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