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
January 14, 2019
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
January 7, 2019
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
December 14, 2018
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
October 22, 2018
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
September 25, 2018
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
August 22, 2018
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...]
FOCUS ON
FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
August 6, 2018
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No Mandatory … [Read more...]
FOCUS ON
FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack
June 19, 2018
In a notice for public comment issued last November, the FDA raised eyebrows by floating a proposal that would make it easier to bring new genetic health risk (GHR) assessment tests to market. The … [Read more...]
FOCUS ON
Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
June 19, 2018
Earlier this month, the FDA finalized new rules designed to relax the regulatory obstacles faced by manufacturers in commercializing new genetic health risk assessment tests. And now an earlier … [Read more...]
