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



Tony Blank –  President of Infinity Biomedical, a small regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Served 12-years at Boston Scientific Corp. in both corporate and business regulatory leadership roles. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products. Since forming Infinity Biomedical, he has been actively engaged with a variety of medical device companies providing crucial support ranging from early phase strategic regulatory planning to post-market compliance to a wide variety of medical device companies in the cardiovascular, ophthalmic, orthopedic, radiology, and oncology fields.  Involved in developing and delivering meaningful educational programs in the field of regulatory affairs and has been a regular speaker at educational events. Blank has been in the medical products industry since 1987 holding roles in R&D, Clinical, Quality and Regulatory Affairs for a variety of organizations. 

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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