The criticism leveled at the Food and Drug Administration (FDA) over the lack of diagnostic tests for COVID-19 in the U.S. belies the unprecedented speed with which new coronavirus tests are reaching … [Read more...]
Emerging Tests
How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed
March 24, 2020
FDA Watch
SARS-CoV-2 Detection Assays Highlight List of Key New Product Approvals
March 24, 2020
Key new U.S. Food and Drug Administration product approvals announced from mid-February 2020 through March 20, 2020 include emergency use authorization (EUA) for eight different commercial tests for … [Read more...]
FDA Watch
FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
March 23, 2020
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA … [Read more...]
Coronavirus
Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing
March 4, 2020
On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US … [Read more...]
FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test
March 2, 2020
Because the 2019 novel coronavirus outbreak was so unanticipated, there were no FDA-approved commercial products for it available in the US during its early days. On Jan. 28, the FDA unveiled its … [Read more...]
FDA Watch
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
January 30, 2020
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
Industry Buzz
Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
January 30, 2020
Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]
GENETIC TESTING
FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
January 24, 2020
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) … [Read more...]
GENETIC TESTING
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
January 3, 2020
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 … [Read more...]
EMERGING TESTS
Zika Antibody Detection Tests Go from Emergency to Commercial Clearance
November 16, 2019
Over the past several years, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did … [Read more...]
