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...]