FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
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Articles and Reports
FDA Proposal for LDTs Risks Serious Consequences
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test
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 that current screening methods that rely on detecting high levels of
FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials
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 guidance allowing companies to submit for simultaneous review for the clinical trial.
FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic tests providing crucial guidance on six key issues.
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
From - Laboratory Industry Report
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against…