New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears

Two draft guidance documents were published 15 September for medical devices with indications for weight loss, Medical Devices with Indications Associated with Weight Loss –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The clinical study draft guidance provides clinical testing considerations, including demographics, statistical analyses and risk-benefit analyses.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.