1. Latest News
  2. Submit Press Release
  1. PR Home
  2. Latest News
  3. Feeds
  4. Alerts
  5. Submit Free Press Release
  6. Journalist Account
  7. PRNewswire Distribution
ComplianceOnline Logo

The FDA’s final Medical Device Data System (MDDS) rule

This session will survey the market affected by the proposed rule, and define the common components and capabilities of these systems.

 
PRLog - Mar. 15, 2011 - PALO ALTO, Calif. -- 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

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. Tim is on the advisory boards of a number of industry publications, and publishes the Medical Connectivity blog.

For more details:
http://www.complianceonline.com/ecommerce/control/trainin...

# # #

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.

--- End ---

Click to Share

Contact Email:
***@complianceonline.com Email Verified
Source:ComplianceOnline
Phone:+1-650-620-3915
Zip:94303
Location:Palo Alto - California - United States
Industry:Medical, Event, Education
Tags:compliance training, web event, web conferencing, web seminar, e-learning, medical devices, Medical Device Webinar Training
Shortcut:prlog.org/11374120
Verified Account Email Address
Verified Account Phone Number

Disclaimer:   Issuers of the press releases are solely responsible for the content of their press releases. PRLog can't be held liable for the content posted by others.   Report Abuse

Latest Press Releases By “

More...

Trending News...



  1. SiteMap
  2. Privacy Policy
  3. Terms of Service
  4. Copyright Notice
  5. About
  6. Advertise
Like PRLog?
9K2K1K
Click to Share