Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Genetics Startup 23andMe Takes Step on Path to FDA Approval."
Following is an excerpt:
Genetics startup 23andMe said on Friday it is one step closer to resuming sales of its full-fledged health product, with the U.S. Food and Drug Administration accepting its first health report for review.
The home genetics company said in a blog post that the FDA will begin evaluating the company's submission for a 510(k) application, a regulatory process that applies to most medical devices sold in the United States. …
Bradley Merrill Thompson, a product regulatory attorney with Epstein Becker & Green, said this was an important "milestone" for 23andMe. The process may still take time, he added, as FDA will likely have further questions or requests for information.
"But this does reveal 23andMe's strategy -- and that's to go through the process with the FDA."
