Artificial intelligence (AI) is becoming widely used in all arenas of life, including the medical device industry. In response to mounting interest in, and application of, artificial intelligence in medical devices, the FDA is actively working on guidance documents that will help align how manufacturers assess risk and ensure safety regarding the use of AI. Two draft documents were released in January of 2025 and are open for comments from the industry until 4/7/2025. It is important that medical device experts review and give input on these drafts before they become final.

FDA Draft Documents

The Association for the Advancement of Medical Instrumentation (AAMI) and The British Standards Institution (BSI) have also collaborated to publish a joint guidance document on artificial intelligence in medical devices (AAMI TIR34971:2023). They hope to present this to the International Organization for Standardization (ISO) to become an international standard in the near future.

If your organization is implementing AI, or needs to understand how AI is starting to revolutionize the medical device industry, contact DPDC! We can review your plans and help steer you in the right direction. DP ensures you have the most current information available from regulatory authorities, and provides expert support to help your device walk the regulatory tight rope all the way to market.