FDA Tells Congress it is Mulling Strategies to Regulate DTC Genetic Tests as Medical Devices | GenomeWeb

Originally published July 23.

By Turna Ray

WASHINGTON, DC – At a congressional hearing on direct-to-consumer genomic testing this week, the US Food and Drug Administration stated unequivocally for the first time that it considers the tests marketed by these firms to be medical devices requiring the agency's clearance or approval. Furthermore, a high-ranking FDA official acknowledged that the agency has waited too long to take action against this rapidly growing industry.

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

A trial upgrade to GenomeWeb Premium gives you full site access, interest-based email alerts, access to archives, and more. Never miss another important industry story.

Try GenomeWeb Premium now.

Already a GenomeWeb Premium member? Login Now.
Or, See if your institution qualifies for premium access.

*Before your trial expires, we’ll put together a custom quote with your long-term premium options.

Not ready for premium?

Browse our free articles
You can still register for access to our free content.

In Nucleic Acids Research this week: personal genome approach to RNA-seq read alignment, hematopoietic Systems Biology Repository, and more.

A man is using DNA evidence to argue that he is the rightful heir to the baronetcy of Stichill, the Guardian reports.

As part of an effort to get a diverse group of people to donate their DNA for research, some blood donors in the San Diego area will get their genomes sequenced, according to KPBS.

The comment period on the Department of Health and Human Services' proposal to alter the Common Rule has been extended.