AdvaMed
While bringing LDTs under FDA oversight could benefit IVD firms, many view the missed opportunity to streamline diagnostic regulation as more significant.
FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests
The rule, which would make explicit FDA's authority to regulate LDTs, is certain to face pushback from many in the laboratory and diagnostics industries.
The proposal could improve the transparency of CMS coverage, but it has limited scope and appears to deprioritize diagnostics compared to other devices.
Dx Industry Faces Challenges Amid Microprocessor Shortage Despite Help From Biden Administration
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With benefits of new legislation some ways out, developers continue to find workarounds to the lack of reliable microprocessor supplies.
VALID Act Divides Dx World as IVD Biz Welcomes Consistency, Flexibility While Labs Fear Red Tape
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A panel discussion at the Next Generation Dx Summit this week provided perspectives on the bill from a variety of industry stakeholders.
Mar 16, 2022
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Sep 20, 2018