On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...more
On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more
On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more
On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more
Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more
4/18/2017
/ 23andMe ,
Clinical Laboratories ,
Food and Drug Administration (FDA) ,
Genetic Markers ,
Genetic Testing ,
Human Genes ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Medical Devices ,
Pharmaceutical Industry
The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more