Hardware Podcasts

#340: LDTs & the FDAs Proposed Ruling

Global Medical Device Podcast · 19 Oct 2023 · 46m · Episode 340

What this episode covers

Shannon Bennett, Director of Regulatory Affairs, joins host Etienne Nichols to dissect the FDA's October 2023 proposed rule to regulate Laboratory Developed Tests (LDTs) as medical devices. Bennett outlines the four-year phased implementation plan, detailing the shift from CLIA oversight to FDA requirements for adverse event reporting, registration, and Quality System Regulation (QSR) compliance. He highlights the massive administrative burden, estimating 80,000 to 100,000 submissions and $55 billion in annual industry costs, while discussing the potential disruption to patient access and the need for clear guidance on risk categorization and new test submissions.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Greenlight Guru, FDA, CMS, CAP
Also
CLIA, Valid Act, EU MDR, ISO 13485

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