Devices, Disruption & the Road Ahead – FDA Watch
Shelly and Wayne chat with Dr. Daniel Schultz, Principal of Medical Devices and Combination Products at Eliquent, and Jonathan Kahan, a Global Regulatory Partner at Hogan Lovells. You’ll hear their thoughts on the effect of CDRH staff reductions on medical device reviews and market authorizations; the outlook for device regulation in the next few years; how FDA is responding to device shortages and supply interruptions; the effectiveness of the current post-market surveillance system in detecting device-related adverse events; the possible effect of eliminating the Freedom of Information staff on the agency’s ability to be responsive and transparent to the public; and much more.
Headlines
Pharma: Drug development is decelerating amid FDA’s staffing cuts
Devices: A federal court shuts down an FDA rule that reclassifies laboratory services as medical devices
Food: FDA did not disclose information surrounding fatal E. coli outbreak linked to lettuce
Cosmetics: PCPC releases statement following FDA’s announcement to phase out animal testing requirements for monoclonal antibodies and other drugs
Resource Links
Pharma and Devices: The Pharma Letter and RAPS release stories on drugmakers and device manufacturers calling for clarity and change to FDA’s guidance on AI in drug development and AI-enabled medical devices
Food: From Reuters, FDA suspends food safety quality checks amid staffing cuts
Cosmetics: Holland & Knight experts discuss FDA’s priorities surrounding cosmetics on recent podcast
About Our Guests
Dr. Daniel Schultz
Dr. Daniel Schultz joined Eliquent following a distinguished 50-year career devoted to supporting and advancing Americans’ public health as a physician, teacher, Food and Drug Administration (FDA) official, member of the US Public Health Service (USPHS) and regulatory expert. He has been recognized many times for his contributions and dedication to public health.
Dan continues his commitment to public health at Eliquent, where he provides strategic consulting services and works with Greenleaf clients to bring safe and innovative devices to patients.
As Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004–2009, Dan was responsible for seven FDA offices and more than 1,000 agency employees. He led the development, implementation, and evaluation of regulatory policies concerning medical devices and radiation-emitting products.
Dan began his 15-year FDA career in 1994 as a Medical Officer in the General Surgery Devices branch of the CDRH’s Office of Device Evaluation. In 1995, he advanced to Chief Medical Officer in the Office of Device Evaluation in the division of Reproductive, Abdominal, ENT, and Radiological Devices. He served as Division Director from 1998– 2001. Dan became Deputy Director for Clinical and Review Policy in the Office of Device Evaluation in 2001 and Director of the Office of Device Evaluation the following year.
During his time at FDA, Dan took advantage of his medical knowledge and experience as Assistant Professor of Surgery at the Uniformed Services University of the Health Sciences and as a member of the Surgical Staff at the National Naval Medical Center in Bethesda, MD.
Before joining FDA, Dan served as a member of USPHS. During postings at Indian Health Service hospitals in Arizona and New Mexico, he provided medical care for people living in the Navajo Nation and Indian Pueblos. Dan received multiple awards for his service, including the Public Health Service Outstanding Medal.
Jonathan Kahan
With more than 40 years of legal experience, Jonathan Kahan is an industry leader in obtaining FDA market clearance of novel medical devices for medical technology and diagnostics companies. He also advises on post-market compliance matters.
Jonathan helps clients navigate complicated regulatory processes, including those related to combination products such as combinations of devices, drugs, biologics, and human tissues. He authored the leading text on medical device law, Medical Device Development: Regulation and Law (Parexel 2020).
Jonathan is the former director of the firm’s Medical Device and Technology practice group and an adjunct professor at the George Washington University Law School teaching medical device law. He presently serves as a member of the George Washington University President’s Leadership Advisory Council and he is also the general counsel of the Association of Medical Diagnostics Manufacturers.
Jonathan is highly ranked by Chambers as well as other legal directories. He has been consistently included in Washington, D.C. Super Lawyers and Washingtonian magazine’s Top Lawyers in D.C. He also received the Food and Drug Law Institute (FDLI) Distinguished Service and Leadership Award, recognizing his contribution in promoting public health, advancing the medical device and technology law field, and ensuring a robust and innovative regulatory environment.
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