FDA’s LDT Oversight Framework Could Impact 60,000+ Tests

The U.S. Food and Drug Administration’s (FDA’s) proposed regulation of laboratory developed tests (LDTs) could affect more than 60,000 genetic tests, according to analysis by Tenn.-based IT firm … [Read more...]

FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics

In a series of three recent FDA Voice blog articles, the U.S. Food and Drug Administration (FDA) surveyed its accomplishments in 2015 and detailed its 2016 agenda. The FDA also separately issued its … [Read more...]


FDA Workshop Addresses Security of Medical Devices

By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Food and Drug Administration (FDA) is joining the cadre of government agencies calling attention to the cybersecurity risks of … [Read more...]

FDA and CMS Address LDT Regulation Before Energy and Commerce Committee

Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug … [Read more...]

FDA Details Oversight of Medical Applications On Smart Phones and Tablets

A new Food and Drug Administration (FDA) final guidance for manufacturers and developers of medical applications used on mobile platforms specifies that the agency will focus its oversight authority … [Read more...]

Final FDA Guidance on RUO, IUO Products Raises Compliance Concerns for Labs

Laboratories that market or sell laboratory-developed tests (LDTs) are facing new compliance challenges because of the Nov. 25 issuance of a final guidance document from the Food and Drug … [Read more...]