The FDA Just Made It a Lot Easier for DNA Health Tests to Hit the Market
November 7, 2017
(Gizmodo) – The newly proposed regulations will allow genetic health tests to make it to market without prior review. Companies seeking to sell such tests would have to come to the FDA for a one-time review. But after getting that initial FDA stamp of approval, any subsequent genetic health test the company develops will not face further regulatory hurdles. “Our goal is to streamline the regulatory pathway to get innovative medical products to people more efficiently, while providing the FDA assurances that consumers seek,” said Gottlieb.