Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
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Diagnostics Pipeline: More AI-Reliant Platforms Being Approved by the FDA
Such assays rely more on imaging and computer power than tissue samples to make diagnoses.
Recent FDA Approvals Show Growing Sophistication of At-Home Tests
Once confined to areas such as pregnancy testing, these assays can now be used to detect STIs and other health issues.
FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.
Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk
FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market
September was an eventful month for one of the hottest products on the consumer genetic test market, the Cologuard multi-target stool DNA test (mtSDNA) for colorectal cancer screening produced by Exact Sciences. The month started badly with the release of a CMS-sponsored research report finding Cologuard “less effective and considerably more costly” than alternatives. Although Exact Sciences quickly criticized the report and its analytical methodology, its stock took a beating.
FDA Watch: Agency Issues New Guidance on Biotin Interference Testing
From - Diagnostic Testing & Emerging Technologies
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform…
