Christina Kuhn

Christina Kuhn

Christina Kuhn provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.

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FDA Initiates Software Precertification Pilot Program

On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice.  The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan.  CDRH also held a webinar on August 1 to provide an overview of the program and answer … Continue Reading

FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan

On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month. The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes … Continue Reading

FTC Releases Online Tool to Help Health App Developers Identify Applicable Laws

On April 5, the Federal Trade Commission (FTC), in conjunction with the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), released a new web-based interactive tool to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and … Continue Reading

OIG FY 2016 Work Plan Includes Review of FDA’s Oversight of Networked Devices

On November 2, 2015, the HHS Office of Inspector General (OIG) published its FY 2016 Work Plan, which summarizes new and ongoing activities that OIG plans to pursue with respect to HHS programs and operations during the fiscal year. The FY 2016 Work Plan includes a new review initiative to examine “whether FDA’s oversight of … Continue Reading

FDA to Focus on “Complementary” Diagnostics in Addition to Companion Diagnostics

Bloomberg BNA reports (subscription required) that FDA will recognize a regulatory category called “complementary diagnostics” for tests that provide additional information about how a drug might be used, but that are distinct from “companion diagnostics,” which are essential for the safe and effective use of a drug.… Continue Reading
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