FDA's Medical Device Software Regulation Strategy

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.

Topics: Seminar by Ex-FDA Official, Regulatory profile for software products, FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance, proprietary software, FDA medical device recalls, warning letters, risk management