The FDA provides options to reduce your pre-market and post-market requirements for software and, therefore, the related cost of compliance. The FDA recognizes that the industry, and not the FDA, holds the technical knowledge required to manage or develop software developments. The FDA also acknowledges that it cannot keep pace with cybersecurity problems – it has tried, but performed poorly, to keep up with the software issues and resilience. Even the FBI has expressed this concern.
Congress has enacted a new legislation to remove low-risk software from the FDA’s jurisdiction. You now have the option of working with other manufacturers to address cybersecurity issues and avoid the need to report your corrective action under the Corrections and Removals regulation (21 CFR Part 806). How that changes FDA’s programs and guidance on software will remain in flux for a few years. As a result, you need to work on developing your organizational plans separate from what the FDA provides.
Join regulatory guidance expert Casper E. Uldriks to discuss the FDA’s options to reduce your pre- and post-market requirements for software. Through the use of an abbreviated 510(k) paradigm, manufacturers have new ways to expedite their market access with new software. The use of voluntary standards lightens the work load on developing and submitting a 510(k) for review. The informational content of the pre-market submission should now be much easier for most software 510(k) submissions. This session will focus on software 510(k) submissions.
On the post-market side of the FDA’s relief options, manufacturers can voluntarily participate in an Information Sharing Analysis Organization (ISAO) to address cybersecurity issues rather than report related corrective and preventive actions to the FDA. These new options have requirements that you must know and satisfy for participation. This session will discuss these requirements.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Casper (Cap) 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 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...
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