FDA Watch: FDA Moves Slowly on AI-Driven Lab Devices
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
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FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
FDA to Continue Remote Regulatory Assessments after Pandemic Ends
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage
Now that the finishing touches have been put on LDT-related legislation, what is the likelihood that it will pass?
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
Congress Looks to Beef up Agency’s Power to Withdraw Unproven AA Drugs
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.
Harmonizing Device CGMP Requirements with International Standards
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A Big Step for CRISPR-Based SARS-CoV-2 Test
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Agency Unveils Guidance for Full Approval of SARS-CoV-2 Tests
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HHS Restores Agency’s Premarket Review of LDTs
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