The US agency has backed away from its intent to oversee laboratory-developed tests as set out in a controversial 2014 draft guidance. Instead, in a new discussion paper it is advising legislation to handle the issue. The agency also urges LDT developers to consider recommendations to increase transparency.

More specific details have emerged about the agreement "in principle" announced last week by FDA and industry negotiators on the next round of the medical device user-fee program, which will extend from fiscal years 2018 through 2022.

FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.