Nearly 250 COVID-19 diagnostic tests have gotten Emergency Use Authorization (EUA) from the FDA since the pandemic started. Almost all of them have been prescription products. In addition, 25 test … [Read more...]
FDA Watch
Respiratory Panel Tests Flow from EUA Pipeline Ahead of Flu Season
October 8, 2020
The robust COVID-19 testing EUA pipeline has opened up a new opportunity for companies that produce multi-analyte panels capable of detecting not only the SARS-CoV-2 virus but other respiratory viral … [Read more...]
FDA
FDA Watch: Agency Finalizes CLIA Waiver Guidance for New IV Devices
March 6, 2020
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here are the highlights. CLIA Waivers The first guidance … [Read more...]
NEW PRODUCTS
FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
February 8, 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...]
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...]
FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test
December 3, 2019
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is … [Read more...]
NEW PRODUCTS
FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials
October 31, 2019
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final … [Read more...]
EMERGING TESTS
FDA Approves Next-Gen Companion Diagnostic
January 16, 2017
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test. The FDA … [Read more...]
