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FDA Proposes Rule on Combination Product Jurisdiction

USA - May 22 2018 On Tuesday, May 15, 2018, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend its regulations concerning how medical...

Tina Papagiannopoulos.


U.S. Food and Drug Administration Proposes Changes to the Premarket Pathway for Genetic Health Risk Tests

USA - November 10 2017 On Nov. 8, 2017, the Food and Drug Administration (FDA) published two final orders and a notice related to direct-to-consumer (DTC) genetic tests...

Torrey Cope.


U.S. Food and Drug Administration Issues Final Guidance On Changes Related to Cleared Medical Device

USA - November 8 2017 After one false start, congressional intervention, a report to Congress and a relatively short interval between draft and final version of the...

Tina Papagiannopoulos, Allison Fulton.


Preliminary Payment Rates Released for New Clinical Lab Fee Schedule; Comments Due October 23

USA - September 25 2017 On Friday, Sept. 22, 2017, the U.S. Centers for Medicare & Medicaid Services (CMS) took an important step toward implementing the sweeping changes to...

Andrew R. Van Haute, Stephanie P. Hales.


U.S. Congress Reauthorizes Food and Drug Administration User Fee Programs, Acts on Other FDA Measures

USA - August 15 2017 After more than two years of negotiations and just before the summer recess, the Senate voted to reauthorize the Food and Drug Administration's (FDA)...

Coleen Klasmeier, Brigid DeCoursey Bondoc, Torrey Cope.