At this conference, now in its second year, attendees will hear top officials from FDA’s Center for Devices and Radiological Health (CDRH) discuss in detail the most significant recent, and upcoming, medical device compliance, regulatory, and enforcement actions. Legal experts will analyze the most important cases of 2012 and detail what to expect in 2013 in litigation and regulatory developments, including key products liability issues. In addition, this conference will explore hot topics in medical device regulation and policy, including: document and data retention; the 510(k) clearance process; Unique Device Identifiers, electronic mobile applications, and the widespread use of social media to communicate with end-users. Attendees will receive these practical takeaways:
- How recent CDRH regulatory and policy developments will impact their organization in 2013;
- What MDUFA III changes mean for medical device manufacturers;
- How new technologies are shaping the development and marketing of medical devices; and
- Why we’ve entered a new era in enforcement of non-compliant medical device manufacturers.