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Basics of 510(k) and Working With FDA

Most medical devices in the US today are marketed under the premarket notification 510(k) authorities of the U.S. Federal Food, Drug, and Cosmetic Act.  In order to market some types of Class I and most types of Class II devices in the United States, 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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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.

Dan Schultz – Former Center Director for the FDA CDRH whose primary objectives included staff leadership of 1,000 employees in the development, implementation and evaluation of regulatory policies concerning medical devices and radiation emitting products. Currently offering client oversight in the regulatory guidance realm which includes pre- and post-market settings. Specific emphasis is placed on insight regarding the FDA regulatory process, labeling requirements and potential regulatory actions for medical devices at Greenleaf Health.

Heather Rosecrans - Brought on by the FDA in 2006 to direct the full implementation of the administrative and regulatory policy for the 510(k) and 513(g) programs which included the classification and reclassification programs within the CDRH through 2010. Currently managing the review of 510(k) submissions, regulatory and policy guidance, and strategic consultation on issues related to FDA’s regulation of medical and combination devices as Executive Vice President at Greenleaf Health.

Get a free chapter on Medical Device Submissions from our Funamentals of US Regulatory Affairs.



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