Kristin Zielinski Duggan
With a background in biology and economics, Kristin Zielinski Duggan provides strategic advice to companies on scientific and U.S. Food and Drug Administration (FDA) regulatory challenges, while always keeping business needs in mind. For the past 17+ years, she has been counseling cutting-edge companies regarding the development and regulation of medical devices, pharmaceuticals, and combination products.
Kristin has a wealth of experience with the entire FDA regulatory process and agency interactions, from devising regulatory strategy for innovative products to pre-submission meetings; to assisting with preclinical and clinical programs and IDEs; to preparing regulatory submissions (510(k)s), de novo petitions and premarket approvals (PMAs); to appeals of agency decisions. Having prepared companies for dozens of advisory panel meetings over the years — including panel meetings to review 510(k) notices and PMAs, general issues panels, and classification panels — Kristin is a top thought leader in this area. She has been involved with all of the meetings of the Medical Devices Dispute Resolution Panel (MDDRP) to date.
Kristin also assists companies with compliance challenges, including 483 and Warning Letter responses, adverse events reporting, recalls, Department of Justice (DOJ) investigations, and product liability litigation, as well as with due diligence for investments and acquisitions.
Kristin's practice covers products in many therapeutic areas, including software products, cardiovascular products, orthopedic and gynecologic implants, plastic and reconstructive surgery devices, radiology devices, gastroenterology devices, wound care products, dental implants, endoscopes and minimally-invasive surgical solutions, and in vitro diagnostics.
Kristin previously served as Vice President for Strategic Consulting at a Washington, D.C.-based scientific consulting firm. Throughout her career, she has published and presented on various FDA regulatory issues.
Helped manage PMA and advisory panel process and secure approval for novel, non-invasive treatment for brain cancer.
Negotiated with FDA to accept a literature review instead of a clinical study for a modification to the materials included in a dental implant.
Prepared 510(k) submission for novel stereotactic neurological guidance system; negotiated outstanding issues, resulting in market clearance.
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Hogan Lovells Publications
16 September 2016