FDA's Medical Device Software Regulation Strategy

The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.

• How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump?
• 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?

medical device trade and healthcare professionals remain plagued by other issues, such as the interoperability of devices from different manufacturers, or software validation that is limited to the immediate use of the software rather than its performance with other software programs, and software hacking protection applications. In case of software malfunction, fixing the malfunction or bug can get more difficult as software gets increasingly sophisticated, customized by users and placed in a network system. Under these circumstances, it is difficult to decide who is responsible for managing and fixing software problems.

This seminar will help those involved in overcoming these commercial and regulatory obstacles. It will highlight the need for firms to remain current with technological tools and strategy to remain competitive, and ideally, outside FDA’s regulatory radar. Going further, it will instruct participants on how to apply these tools and strategies to ensure the following factors:

• Software functionality
• Risk identification
• Software protection
• Problem detection
• Response strategy

This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies.