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Regulatory Strategies for Medical Device Market Clearance – the 510(k) pathway

UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)

Friday, April 14, 2017 from 9:00 AM to 5:00 PM (PDT)

Ticket Information

Type End Quantity
UCSF Student Apr 11, 2017 Free  
UCSF Postdoc Apr 11, 2017 Free  
Stanford Student Apr 11, 2017 Free  
Stanford postdoc Apr 11, 2017 Free  
Genentech interns Apr 11, 2017 Free  
UCSF/Stanford Staff Apr 14, 2017 Free   Add to Waitlist

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Event Details

This session builds on the foundations discussed in the first session of the medical device series of UCSF-Stanford CERSI mini-courses.  Upon completion of this session, students will be able to:

  • describe the 510(k) submission process and the circumstances that apply for each type of submission
  • explain the definition of “substantial equivalence” and how it is determined
  • review the process for determining if a device change requires a new or special 510(k), or requires no 510(k)
  • list the steps in generating traditional 510(k) and de novo 510(k) submissions
  • utilize with FDA resources to help with producing 510(k) submissions

Prerequisites

Basic understanding of FDA regulation of medical devices, e.g. completion of CERSI mini-course "Introduction to U.S. Device Regulation".

Instructors

Mary Ann Smith, Regulatory Policy Head for Digital Medicines and Medical Devices, NOVARTIS PHARMACEUTICALS CORPORATION

Branden Reid, Ph.D., is a Global Regulatory Affairs Lead at Becton, Dickinson, and Company (BD) in the Preanalytical Systems business unit.

 

 

 

 

Have questions about Regulatory Strategies for Medical Device Market Clearance – the 510(k) pathway? Contact UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)

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When & Where


James Clark Center, S361
318 Campus Drive
Stanford, CA 94305

Friday, April 14, 2017 from 9:00 AM to 5:00 PM (PDT)


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Organizer

UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)

Center of Excellence in Regulatory Science and Innovation is a partnership between University of California San Francisco (UCSF), Stanford University and U.S. Food and Drug Administration (FDA).

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Regulatory Strategies for Medical Device Market Clearance – the 510(k) pathway
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