On-demand Program: FDA Hot Topics: 2015 Update on Medical Device Guidances (On-demand Program)

So much has transpired in the last year with the Food and Drug Administration (FDA) that it is hard to keep up with all the new initiatives represented in a myriad of new agency guidance documents. Join RAPS, Wednesday 9 September, with industry-leading speakers in a half-day virtual program to discuss some hot topics including FDA’s guidance on Investigational Device Exemptions (IDEs), benefit-risk factors to consider for 510(k) notifications, FDA’s final guidance on Medical Device Data Systems (MDDS) and mobile medical apps (MMA), an update on the de novo classification process and the difference between medical device recalls and enhancements.

This program is designed to update the audience and provide insights from thought leaders on each topic. The speakers will share with the audience the highlights of these guidance documents and insights regarding how they are working in practice for industry, with tips on how to interpret and respond to them. This information will be vital for new and seasoned regulatory professionals working with these guidance documents.

Learning Levels: Basic and Intermediate

Learning Objectives:
Upon the webcast's conclusion, you will be able to: 

  • Provide a compact/quick update on some FDA hot topics
  • Discuss the basics of these FDA guidance documents
  • Review some of the deficiencies and problems with these guidance
  • Give some insight on how to deal with them going forward

Who Should Attend?

  • Regulatory professionals
  • Clinical professionals
  • R&D personnel
  • Quality systems personnel
  • Marketing and sales professionals