Gastroenterology and Artificial Intelligence: 2nd Annual Artificial Intelligence Summit | October 2020-Streamlining FDA Regulatory Approvals

Streamlining FDA Regulatory Approvals_Antonino

Pdf Summary

The document discusses the regulatory pathway and requirements for the approval of artificial intelligence (AI) devices in the field of gastroenterology. It explains that medical devices are classified into Class I, II, and III, with regulatory control increasing from Class I to Class III. Most Class I devices are exempt from Premarket Notification, while most Class II devices require a Premarket Notification 510(k) clearance based on substantial equivalence to a predicate device. Most Class III devices require a Premarket Approval (PMA). <br /><br />For AI devices for polyp detection, which have not yet been cleared or approved in the United States, they may be eligible for a De Novo designation. The De Novo pathway allows for the classification of novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness but no legally marketed predicate device exists.<br /><br />The document also provides an overview of AI studies for polyp detection, emphasizing the importance of prospective clinical studies with co-primary endpoints such as Adenomas Per Colonoscopy (APC) and Adenomas per Endoscopy (APE). It suggests that a tandem study design, which involves two colonoscopies per patient (AI then non-AI examination or vice versa), can be considered. <br /><br />Furthermore, the document highlights the importance of non-clinical testing to assess algorithm modifications and provide accurate performance data. It also mentions the FDA's Q-Submission program, which allows companies to obtain FDA input through pre-submission activities.<br /><br />In summary, the document emphasizes the regulatory requirements and recommendations for the approval of AI devices for polyp detection in the field of gastroenterology, including the De Novo pathway, prospective clinical studies, non-clinical testing, and engagement with the FDA through the pre-submission program.

Keywords

regulatory pathway

approval

artificial intelligence devices

gastroenterology

medical devices

Premarket Notification

Premarket Approval

De Novo designation

prospective clinical studies

non-clinical testing