1. Medtech Insight

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

 
• By Hannah Daniel

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

A woman flipping through a stack of documents
• Source: Shutterstock

Two draft guidance documents were published 15 September for medical devices with indications for weight loss, Medical Devices with Indications Associated with Weight Loss –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The clinical study draft guidance provides clinical testing considerations, including demographics, statistical analyses and risk-benefit analyses.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

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