At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software.

The FDA’s Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA’s list of priorities to be finalized in 2022. 

• According to the FDA, CDS software “provides healthcare professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”
• As with most regulations and guidances, the verbiage used for CDS software is ambiguous and makes room for interpretation or manipulation.
• There are a few reasons why the FDA is making CDS software important and its #1 priority. More companies and customers are or want to work and produce products in this space.
• For now, CDS software is not regulated by the FDA due to limited resources. However, that will change when companies’ products provide wrong or inaccurate information. Nobody or not too many people have been harmed, yet.
• According to Mike, CDS software provides clinicians as well as patients with information to enhance health and health care. Examples of CDS software include telehealth and AI platforms that ask patients questions about their health.
• FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person - not by a device or software.
• Make sure that CDS software properly provides accurate information because there can be major product liability implications if not regulatory ones.
• Regulated or not, usability testing is a must. What if your software tells patients they don’t have a problem, but actually do, and wait to take care of it? 

“I’ve got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space.”

“Right now, much of this is not being regulated by the FDA. The FDA - they’re using their enforcement discretion to not regulate.”

“FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person.”

 “As soon as the practice of medicine is being practiced by a device or in this particular case, software, now all bets are off.”

Clinical decision support guidance tops FDA’s agenda for 2022 (Med City News) (Oct. 29, 2021)

FDA's 2022 A-list guidance plan hits on software, post-pandemic future

CDRH Guidance: Clinical Decision Support Software (September 2019)

FDA - Medical Devices

Software as a Medical Device (SaMD)

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