Warning Letter Close-Outs – November 2017
US FDA released seven device-related close-out letters in November.
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The agency urges sponsors to keep patient safety “first and foremost” in determining how to continue a clinical trial during a natural disaster, public health emergency, or other crisis.
News We're Watching: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients
This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.
Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.