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?

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

The 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

For those who have addressed these issues to meet FDA’s regulatory expectations, the course instructor, a former FDA official, will help identify a basic centering point to build a regulatory profile for your software products.

Learning Objectives:

• Understanding FDA legal authority
• Applying FDA classifications / risk controls
• Understanding FDA and NIST software guidance
• Identifying the quality system regulation for risk management, software verification and validation
• Identifying cybersecurity issues and developing a planned response
• Identifying and resolving interoperability issues
• Figuring out the scope of FDA’s mobile apps regulation
• Learning about bug updates classified as recalls by FDA
• Future device software applications

Who Will Benefit:

• Regulatory Affairs Managers
• Quality Assurance Managers
• Software Design Engineers
• Manufacturing Managers
• Compliance Department Personnel
• Hospital Risk Department Personnel
• Software Program Marketers
• IT Security Managers
• Marketing Personnel