Basics of 510(k) 

15-16 November 2018 
Las Vegas, Nevada
 
Most medical devices in the US today are marketed under the premarket notification (510(k)) authorities of the Federal Food, Drug, and Cosmetic Act. In order to market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to what is required in other jurisdictions, the regulatory requirements and the submission process are very different. The purpose of this workshop is to provide participants with an understanding of the regulatory fundamentals; practical guidance on how to develop, prepare and submit a 510(k) to FDA; and how to engage with FDA.

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10 RAC recertification credits upon completion of the program

 

Faculty

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Donna-Bea Tillman – Former Director FDA/CDRH, Office of Device Evaluation whose primary objectives included managing clinicians responsible for the premarket review of medical devices in the US. Currently advising clients on short and long term regulatory strategies for medical devices and combination products, including the regulatory requirements that may apply to software used in a medical environment. Focus also includes assisting with the development of medical device regulatory submissions that include 510(k), PMA, HDE, RFD, 513(g), preSub, and IDE at Biologics Consulting.




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Publications

  • Fundamentals of US Regulatory Affairs, 10th Edition
    The 10th edition of Fundamentals of US Regulatory Affairs presents information covering all lifecycle stages of regulated healthcare products. More than 50 authors contributed to the content, which is current through May 2017. New chapters in this edition include preclinical and clinical chapters on drugs and medical devices, biosimilars, and traceability and supply chain.
  • Fundamentals of US Medical Device Regulations
    Derived from the 10th edition of Fundamentals of US Regulatory Affairs, this book focuses on legislation and regulations for medical devices in the US. It also examines US Food and Drug Administration’s (FDA) history and the development of the regulatory environment, and the regulatory pathways available for all healthcare product submissions. Both devices and in vitro diagnostics (IVDs) are included in this volume.
  • US Regulatory Acronyms & Definitions, Seventh Edition
    This definitive guide to the most common terms and definitions in the US regulatory field is ideal for new and experienced regulatory professionals. Whether you’re looking for the acronym for a new regulation or the definition of an industry-specific term or a drug, you’ll find an entry for relevant vocabulary across the regulatory spectrum.

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