Information is provided in this section of the Nu Device LLC website as an aid to understanding the regulatory process. While every effort is made to offer comments, articles, links and news updates which are accurate and up-to-date, no liability is assumed with respect to the use of this information. When contemplating strategic decisions or determining when an application, license or permit is needed, please consult with an experienced professional.
General Information
U.S. Food and Drug Administration Regulation of Medical Devices
Review of the Processes for FDA Oversight of Drugs, Medical Devices, and Combination Products
Wrecking Ball: FDA Regulation Of Medical Devices
What You Don’t Know About De Novo – A Primer For Medical Device Companies
What Every Foreign OEM, Importer Should Know
Letter to Industry about Import Entry Review Process (March 24, 2011)
FDA's PREDICT Screening System for Entry of Foreign Products
Tips for Effectively Responding to a Form FDA-483 for Foreign Medical Device Manufacturers