FDA's New Attitude Toward Medical Software

Medical software background
Medical software is a specialized branch of software engineering in which the software is used to monitor or control patient functions and records. Examples of typical products include monitors, medication pumps, scanners and analyzers, expert systems, medical informatics, therapy delivery, healthcare educational software, and EMR/EHR software. In 2008 around 45% of new 510(k) described products had medical software.

Device firms have not kept pace
"The problem with testing software is that even very basic applications have so many variables and permutations of outcomes that verification and validation testing is unreliable. Instead, in 2002 FDA focused its guidance on assuring vendors followed accepted design processes," reported Tim Gee in Medical Connectivity.

Product recalls continue to increase
The number of product recalls associated with medical software more than doubled from 10% to 21% over the decade ending in 2006. With the importance of electronic medical record-keeping under the current administration, you can expect FDA's scrutiny of medical software to increase even more.

Device industry has not kept pace
In a June 2007 workshop titled "High Confidence Medical Devices, Software, and System and Medical Device Plug-and-Plan Interoperability", the concept of static analysis of medical software was discussed over and over again, reported Mr. Gee. "The bottom line is that the medical device industry has not kept up with other high reliability industries such as aviation or automation."

In this e-conference

Learning objective
FDA's policies regarding regulation of medical software are rapidly evolving.  As the agency considers expansive regulation of new types of software, software development and validation methodology, and expectations of performance and reliability, it is important to understand the scope of potential regulation and the level of regulation that may be applied.

You will receive
[x] PowerPoint Slides.
[x] An expert speaker.
[x] Opportunity for QnA
[x] Certificate & CEUs.

Audience suitability
[x] People who work with data
[x] People who design and implement software
[x] Regulatory professionals
[x] Executives who are planning their companies futures

Presenter
Janice Hogan is a partner in the offices of Hogan and Hartson LLP and a member of the firm’s Food, Drug, Devices, and Agriculture Group. Her practice focuses on the representation of medical device [and other] manufacturers before FDA. She is a biomedical engineer and specializes in regulatory counseling related to high technology medical products. You can reach Ms. Hogan at http://www.hhlaw.com/jmhogan/

The purchase is $424 for OnDemand access and $474 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.