Digital Health Regulation: Navigating FDA’s Rules for Software as a Medical Device
The FDA has been regulating medical device hardware for years but the development of standalone software being used as a medical tool has forced the agency to expand its guidelines. With that expansion has come a new designation — software as a medical device (SaMD) — and a new set of rules.
Understanding these new rules is critical to the success of new software applications.
Digital Health Regulation: Navigating FDA’s Rules for Software as a Medical Device will help you pinpoint the differences between conventional medical device regulations and those used for SaMDs, along with the unique risks and challenges they present. You’ll discover how automated systems could improve your FDA submissions process and the importance of keeping regulatory requirements in mind as you develop new software products.
This management report — based on a webinar presented by digital health regulations expert Shahid Shah — provides a detailed analysis of the updated regulations, including:
- The Differences Between Conventional and SaMD Regulations
- The new pathway for SaMD regulations
- Applying regulatory requirements to software-intensive devices
- The unique and novel risks of software-intensive medical devices
- How software-intensive devices impact the healthcare ecosystem
- The difficulties and benefits of the SaMD pathway vs. 510(k) clearance
- How automated systems could reduce preparation time for FDA submissions
- Building regulatory practices directly into systems development lifecycles
- Easing inspection and audit burdens
- Creating more reliable results in the SaMD development process
- The role of artificial intelligence and machine learning
- Discretion in regulating digital health tools and software
The FDA moves SaMDs through a different regulatory pathway than most medical devices and their associated software — so you need to prepare for a new set of guidelines. In this management report, you’ll find expert tips for creating the most effective software development process possible and getting the FDA’s approval.
About the Contributor
Shahid Shah is a health IT and medical device software integration expert with more than 31 years of experience. He has built both conventional 510(k) and SaMD solutions and has been educating the industry about medical device interoperability and regulatory science for many years. This report is based on a webinar presentation from Shah on the subject of digital health regulations.
Who Will Benefit
- Marketing leaders
- Regulatory affairs leaders
- Regulatory compliance professionals
- Product managers
- Quality assurance professionals
- Research and development teams
- Submissions and approvals staff
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