Overview: The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Why should you Attend: Anyone who is involved in software and device design, modification, manufacturing, quality testing and distribution should be aware of these changes and the impact on decision-making as to whether or not to prepare a new 510(k). The FDA provides flowcharts that guide the reader to the best decision, but some judgment is also required. Areas Covered in the Session: Medical Device changes Software Application changes for software used in conjunction with medical devices FDA Guidance Documents FDA Enforcement New 510(k) submission Who Will Benefit: Information Technology (IT) Analysts IT Developers IT Support Staff QC/QA Managers and Analysts Clinical Data Managers and Scientists Analytical Chemists Speaker Profile: Carolyn (McKillop) Troiano Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: [email protected]