Why Should You Attend:
The FDA signaled a shift from regulatory discretion to enforcement discretion regarding Medical Device Data Systems (MDDS) with the publishing of the final rule on February 14, 2011. Ostensibly, the FDA reclassified these systems from Class III to Class I. But the most remarkable consequence from the final rule is naming of specific entities that may be subject to potential FDA enforcement actions.
The rapid adoption of Electronic Medical Records, advent of Meaningful Use and subsequent desire to automatically acquire medical device data for inclusion in electronic records has resulted in the development and adoption of Medical Device Data Systems. FDA has observed the evolution of this market for some years, and the agency's mandate to ensure patient safety has motivated it to publish this final rule.
This webinar will compare and contrast the proposed and final rule, and discuss what systems and products meet the definition of a MDDS. The named entities that may be subject to enforcement will be discussed, including the FDA's rationale for enforcement authority. Effective compliance dates and required actions will be presented.
Recommended actions in response to the final rule will be presented for each of the applicable groups: regulated manufacturers, unregulated manufacturers and health care providers.
Areas Covered in the Seminar:
Who Will Benefit:
Manufacturers and providers facing regulatory uncertainty will benefit from a better understanding of the final rule, allowing them to more effectively plan their response and achieve compliance within the rule's effective dates.
Tim Gee, is the founder and Principal of Medical Connectivity Consulting, and specializes on the convergence of medical devices and information systems. Tim provides consulting services to both vendors and providers. He speaks frequently at industry conferences and corporate events. Tim is on the advisory boards of a number of industry publications, and publishes the Medical Connectivity blog.