FDA's Medical Device Software Regulation

Why Should You Attend:

The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances, clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports that FDA will integrate into its regulatory oversight.

Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Can one software program defeat the performance capability or back up safety features of another software program? When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

These issues will be highlighted during the webinar. The issues require careful consideration, given that no obvious answer appears at hand.

Areas Covered in the Webinar:

• FDA software guidance
• National Institute of Science and Technology guidance reports
• Cybersecurity
• Interoperability
• Mobile apps
• Software validation
• Software recalls

Who Will Benefit:

• Regulatory Affairs
• Quality Assurance
• Software Design Engineers
• Manufacturing
• Complaint Dept.
• Hospital Risk Dept.

Instructor Profile:

Casper Uldriks brings over 32 years of experience from the FDA. He specializes in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Mr. Uldriks is the president of Encore Insight, LLC, a consulting service for FDA matters.

Topic Background:

For decades, firms have experienced serious problems with software and have been at a loss to make a well-informed follow up. Software problems represent one of the most common root causes for recalls that are associated with deaths and serious injuries beyond what should be necessary to quantify. FDA sees firms revise software only to create more problems rather than solve them. The infusion pump industry is a classic example that drove FDA to implement a new rigorous paradigm for device evaluation.

Software use has become increasingly complicated with the expansion of software applications, for example: stand-alone software, cybersecurity, interoperability, mobile medical "apps," home use and remote use. The FBI has warned the healthcare industry and the FDA that it is not prepared to manage cybersecurity. Almost all hospitals experience devices that do not work together, which is a financial thorn. Another growing concern is the public's use of standalone software programs to manage their health issues with a mobile app rather than go to a healthcare professional.

The FDA’s regulatory approach relies on new premarket review criteria concerning software. Premarket design requirements must factor in software failures from the past, vis-à-vis complaints, medical device reports and recalls. Software problems has been a frequent reason for recalls for decades. As software expands, so do the problems. The FDA’s regulatory program relies on basic regulatory requirements and software design and performance issues. Now, the federal government, include the FDA, have partnered with the National Institute of Standards and Technology (NIST) to move forward in a technologically current manner. You need to know how to move forward with software and intelligently mitigate the inherent risks software presents.

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