The Burrill Report


The Burrill Report (August 6, 2012): Regulate Me (.MP3,14.96 Mb)

The personal genetics company 23andMe said it has delivered its first round of 510(k) documentation to the Food and Drug Administration in an effort to win FDA clearance for aspects of its personal genome service. The company says it is the first in the industry to announce it is working towards FDA clearance. We spoke to Dan Vorhaus, editor of The Genomics Law Report and an attorney with Robinson Bradshaw and Hinson, about 23andMe’s decision to seek FDA clearance, why the company is taking the unusual step, and what the regulatory process might look like for 23andMe and others that follow.

August 02, 2012
http://www.burrillreport.com/article-regulate_me.html