FDA

Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay

As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval. So, when the product undergoes significant changes, it often triggers … [Read more...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane¬†bio and Elaine Naughton¬†bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]

NEWS

Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy

Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. But while his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]

FDA

FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests

While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul. For several years, the FDA, Congress and lab industry have been working together … [Read more...]

MARKETING

Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service

The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect 33 variants for multiple … [Read more...]

FOCUS ON

LDTs: FDA Announces New Approach to 510(k) Approvals

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]

PUBLIC HEALTH

FDA Watch: Agency Approves New Flu Tests and Drug

As the flu season begins, the FDA has issued significant approvals of new products for diagnosing and treating the disease. New Flu Assays On October 24, Abbott announced that the FDA has granted … [Read more...]

FDA

FDA Biological Products Agency Issues New Recommendations for Emergency Weather Response

With another hurricane season wreaking havoc, the FDA's Center for Biologics Evaluation and Research (CBER), which regulates biological products for human use, is calling on labs to pay attention to … [Read more...]

FDA

LDTs: FDA Does an End Run on Regulatory Proposal Lab Industry Helped Create

A couple of years ago, the lab industry played an active role in the drafting of the Diagnostic Accuracy and Innovation Act (DAIA), a bill designed to establish a new regulatory regime for laboratory … [Read more...]

PUBLIC HEALTH

New Zika Blood Testing Guidance Effective Immediately

On July 6, the FDA issued revised guidance for testing of donated blood for Zika virus. Summary After initially recommending universal nucleic acid testing of individual blood donation units, the … [Read more...]


(-00000g2)