The clinical trial scheme of the third kind of medical devices implanted in the body or made by borrowing the theory of traditional Chinese medicine, which has not yet appeared in the market, shall be filed with the technical evaluation institution of medical devices.
The State Food and Drug Administration of the United States can formulate a unified clinical trial plan for similar medical devices that have been listed and have adverse events or unclear curative effects.
To carry out clinical trials of such medical devices, implementers, medical institutions and clinical trial personnel shall implement the provisions of a unified clinical trial plan.
The clinical trial scheme of medical devices should determine the number of clinical trials, duration and clinical evaluation criteria according to the characteristics of specific tested products, so as to make the test results statistically significant.
The clinical trial scheme of medical devices shall prove the basic information of the theoretical principle, basic structure, performance and other elements of the tested products and the safety and effectiveness of the tested products.
The clinical verification scheme of medical devices shall prove whether the main structure, performance and other elements of the tested products and the products already on the market are substantially equivalent, and whether they have the same safety and effectiveness.
The clinical trial scheme of medical devices shall include the following contents:
(a) the theme of the clinical trial;
(2) The purpose, background and content of the clinical trial;
(3) Clinical evaluation criteria;
(4) Risk and benefit analysis of clinical trials;
(five) the name, position, title and department of the clinical trial personnel;
(six) the overall design, including the possibility analysis of success or failure;
(seven) the duration of the clinical trial and the reasons for its determination;
(eight) the number of clinical trials of each disease and its reasons;
(nine) select the scope of the object, the number of objects and the reasons for the selection, and set up a control group when necessary;
(ten) therapeutic products should have clear indications or scope of application;
(eleven) evaluation methods and statistical processing methods of clinical manifestations;
(twelve) side effects prediction and measures to be taken;
(13) informed consent of the subject;
(14) responsibilities of all parties.
The medical institution and the implementer sign a mutually agreed clinical trial plan and a clinical trial contract.
Clinical trials of medical devices shall be conducted in more than two (including two) medical institutions.