The presentation will consider potential impacts of the rule on regulated and unregulated vendors, and providers. This session will survey the market affected by the proposed rule, and define the common components and capabilities of these systems.
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.
What systems and products meet the definition of a Medical Device Data System?
How the proposed MDDS rule applies to a sample of existing products?
Potential targets of FDA enforcement called out in the final MDDS rule.
Effective dates for compliance.
Potential impact of the final rule on regulated vendors, unregulated vendors, and providers.
Potential costs and operational impacts of the proposed rule.
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:
How the final version of the rule differs from the proposed rule?What systems and products meet the definition of a Medical Device Data System?
How the proposed MDDS rule applies to a sample of existing products?
Potential targets of FDA enforcement called out in the final MDDS rule.
Effective dates for compliance.
Potential impact of the final rule on regulated vendors, unregulated vendors, and providers.
Potential costs and operational impacts of the proposed rule.
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.- Medical device manufacturers, health care IT vendors, value added resellers, and dealers
- Health care provider organizations using MDDS
- Product managers
- Risk managers
- Biomedical/clinical engineers
- Regulatory affairs personnel
Course Provider
Tim Gee,
