Two draft guidance documents were published 15 September for medical devices with indications for weight loss, Medical Devices with Indications Associated with Weight Loss – Clinical Study and Benefit-Risk Considerations and Medical Devices with Indications Associated with Weight Loss – Non-Clinical Recommendations.
The clinical study draft guidance provides clinical testing considerations, including demographics, statistical analyses and risk-benefit analyses. There are also examples for risk-benefit factors assessments from a clinical study.
The non-clinical study draft guidance lists considerations for using non-clinical testing to influence pre-market submissions, labeling, sterility and animal studies.