FDA officials: next year, there will be a large number of medical AI listing reviews.
2018-07-13
"It is expected that next year there will be a large number of independent medical Al software entering the stage of listing review." Sun Lei, director of the Medical Devices Technical Review Center, said July 2 that the center has not yet received an application for listing medical Al products submitted by the enterprise. However, based on the development trend of medical AI at home and abroad, the center has set up a Al research group to study related technical reviews.
The medical instrument technical review center was established in 1996. It is the direct unit of the State Administration of food and Drug Administration (normal local level). The main function is to review the technical review of the third kinds of medical instruments and imported medical instruments.
In recent years, the center has established a mechanism for review work by a team review team composed of clinical medicine, clinical diagnosis, biomedical engineering, biomedical engineering, material science and statistics, for innovative, priority, important and difficult products, clinical trial approval projects and the first product of the same variety. In order to improve the level of professionalization and science of the review, the evaluation system of the project team team is gradually established with clinical guidance and review as the core.
Since the implementation of the new special approval procedure in 2014, the center has conducted a technical review of 58 products entering the innovative special approval channel, implantable cardiac pacemaker, percutaneous interventional artificial heart valve system, vascular reconstruction device, abdominal aorta covered stent system, miR-92a gene expression level detection kit (fluorescent RT-P). 34 items, such as CR, are reviewed and allowed to be listed. Since the implementation of the priority examination and approval process in January 2017, the center has conducted technical reviews on 15 items that have entered the priority examination and approval channel, and 5 items such as drug elution balloon catheter, hollow fiber membrane hemodialysis filter and so on are reviewed and approved to be listed.
According to Sun Lei, at present, the center has standardized and formed 5 kinds of consultancy and communication systems, covering the pre application of the registration application, before the application of clinical trials to be examined and approved, the process of review, and the review process of the review and approval of the products. Medical device enterprises can communicate with each other through various channels to get business guidance and technical support.
