FDA Center for Devices and Radiological Health

23andMe gets FDA's go-ahead to sell genetic health risk tests, opening the door for faster approval for future tests

By Heather Mack 03:35 pm April 7, 2017

In a true first, the Food and Drug Administration is allowing 23andMe to sell its direct-to-consumer genetic test kits that provide information about an individual’s risk to certain diseases such as Alzheimer’s or Parkinson’s disease. 23andMe’s $199 genetic tests are available with the FDA’s blessing nearly three and a half years after the agency first ordered 23andMe to immediately stop selling...

FDA recognizes device interoperability standards, potentially smoothing 510(k) reviews

By Neil Versel 05:11 am August 13, 2013

FDA Senior Policy Advisor Bakul Patel A decision by the Food and Drug Administration to recognize a set of voluntary, industry-developed interoperability standards should make it easier for technology developers to gain 510(k) clearance for new medical devices – including smartphone accessories – that follow such standards. In its annual update to its list of accepted consensus standards for...