Advanced medical devices increasingly rely on AI-driven frameworks to automate compliance processes, ensuring safety and efficacy while reducing regulatory burdens. In the United States, software-based medical devices, including those utilizing AI/ML models, are regulated by the FDA's Center for Devices and Radiological Health (CDRH) under the Code of Federal Regulations (CFR) Title 21. These regulations are extensive, cross-referenced documents that require significant human effort to parse, leading to high compliance costs for manufacturers. We propose a novel, semantically rich framework that extracts regulatory knowledge from FDA documents and translates it into a machine-processable format. Our system encodes regulatory knowledge into an OWL/RDF-based knowledge graph and uses the Mistral 7B Instruct model to dynamically generate SPARQL queries, perform compliance reasoning, and produce structured reports. This enables automated device classification (Class I, II, or III) and real-time regulatory evaluation. Validated through real-world use cases, our framework significantly reduces manual review effort, enhances interpretability, and accelerates time-to-market. The proposed approach integrates AI reasoning and semantic technologies to achieve scalable, transparent, and automated regulatory compliance.

Healthcare providers are deploying a large number of AI-driven Medical devices to help monitor and medicate patients. For patients with chronic ailments, like diabetes or gastric diseases, usage of these devices becomes part of their daily lifestyle. These medical devices often capture personally identifiable information (PII) and hence are strictly regulated by the Food and Drug Administration (FDA) to ensure the safety and efficacy of the medical device. Medical device regulations are currently available as large textual documents, called Code of Federal Regulations (CFR) Title 21, that cross-reference other documents and so require substantial human effort and cost to parse and comprehend. We have developed a semantically rich framework MedReg-KG to extract the knowledge from the rules and policies for Medical devices and translate it into a machine-processable format that can be reasoned over. By applying Deontic Logic over the policies, we are able to identify the permissions and prohibitions in the regulation policies. This framework was developed using AI/Knowledge extraction techniques and Semantic Web technologies like OWL/RDF and SPARQL. This paper presents our Ontology/Knowledge graph and the Deontic rules integrated into the design. We include the results of our validation against the dataset of Gastroenterology Urology devices and demonstrate the efficiency gained by using our system.