The presentation will consider potential impacts of the rule on regulated and unregulated vendors, and providers.
On February 8, 2008 the FDA published a proposed rule defining Medical Device Data Systems (MDDS) as a system that acquires and transfers medical device data from medical devices for any or all of the following: storage and retrieval, display, and conversion of data from one format to another. The FDA proposes reclassifying these systems from Class III to Class I. This proposed reclassification impacts many vendors and providers who have thus far escaped regulatory oversight. This session will survey the market affected by the proposed rule, and define the common components and capabilities of these systems. After a review of the relevant regulatory history, the proposed definition of the affected systems will be discussed in detail. Effective dates included in the proposed rule will be presented. The proposed rule will be applied to various types of commercially available systems. The presentation will consider potential impacts of the rule on regulated and unregulated vendors, and providers. Costs and operational impacts will also be discussed. Finally, the presentation will close with a review of common questions and issues raised in comments submitted to the FDA in response to the proposed rule.
Areas Covered in the seminar:
- Market survey of systems that integrate with medical devices.
- Common systems components and capabilities of currently available solutions.
- Regulatory history.
- Definition and characteristics of a Medical Device Data System.
- Effective dates for compliance.
- How the proposed MDDS rule applies to a sample of existing products.
- Potential impact of the proposed rule on regulated vendors, unregulated vendors, and providers.
- Potential costs and operational impacts of the proposed rule.
- Review of comments submitted to the FDA in response to the proposed rule, and common questions.
Who will benefit:
Vendors and providers facing regulatory uncertainty will benefit from a better understanding of the market and the proposed rule, allowing them to more effectively plan for the release of the final rule and the achieve compliance within the rule’s effective dates.
- Medical device vendors, 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
- Medical Connectivity Consulting
Instructor Profile:
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. Recently he has spoken at the AAMI 2007 Conference, Healthcare Unbound, HCMDSS/MD PnP Workshop, and other venues. Tim is on the advisory boards of a number of industry publications, and publishes the Medical Connectivity blog.
