Devices

Clarifications Sought in Diagnostic Device Guidance

Three stakeholder trade associations are asking FDA to clarify some aspects of a draft guidance on principles for co-development of an in vitro companion diagnostic device with a therapeutic product. The Biotechnology Innovation Organization says it supports the agency’s efforts to provide a practical regulatory guide for sponsors engaged in developing a therapeutic product and an accompanying IVD companion diagnostic. “In general,” the letter says, “the draft guidance is helpful in describing general principles to guide co-development for contemporaneous therapeutic product and device marketing authorizations, regulatory requirements, administrative, and clinical trial planning/execution considerations.” It asks that FDA clarify regulatory requirements for approval of complementary diagnostics through a guidance on that topic and a discussion of appropriate regulatory principles to compare and contrast to companion diagnostics.

AdvaMedDx says the guidance “captures substantial FDA expertise in personalized medicine and is a positive step in supporting innovators who are bringing new safe and effective diagnostic technologies to the U.S. to advance personalized medicine.” It says this effort fits well with the administration’s precision medicine initiative and its Cancer Moonshot through policies aimed to support innovation in personalized medicine for patients. The association highlights particular language that could benefit from clarification or revision.

Finally, Pharmaceutical Research and Manufacturers of America (PhRMA) says it would like “further granularity regarding the criteria used to assess risk determination for investigational IVDs used in therapeutic clinical trials. PhRMA believes it would be helpful for the agency to discuss several specific instructive examples in an appendix to this draft guidance to assist sponsors during risk determination.” It also asks for clarification on when an IDE application must be submitted for an investigational IVD companion diagnostic that is studied in a therapeutic product clinical trial.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome