In recognition of the growing influence of artificial intelligence (AI) in new and innovative technologies, the U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to guide manufacturers in gaining approval for AI-enabled medical devices.
Issued in early January, the Draft Guidance, titled “Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” provides recommendations for medical device manufacturers on the design and development of AI-enabled devices using a total product life cycle (TPLC) approach. The Draft Guidance also includes information on the FDA’s current thinking about strategies that device manufacturers can use to address “transparency and bias” through the TPLC of AI-enabled devices, with the goal of ensuring the safety and effectiveness of devices for their intended use by all demographic groups.
Finally, the Draft Guidance includes recommendations on documentation and other information that should be included in device marketing submissions submitted to the agency.
The recommendations contained in the Draft Guidance are reportedly based on the more than 1000 AI-enabled device applications already reviewed and authorized by the FDA through existing premarket pathways.
The FDA’s Draft Guidance on AI-based medical devices is available at https://www.fda.gov/media/184856/download.
Comments on the Draft Guidance can be submitted through the beginning of April at the Regulations.gov website at https://www.regulations.gov/docket/FDA-2024-D-4488/document (Reference Docket Number FDA-2024-D-4488).
