A decade in the making, the US Food and Drug Administration (FDA) has published two complementary draft guidances for sponsors developing weight-loss devices. The documents outline the agency’s thinking on the types of studies that are appropriate for premarket applications, trial endpoints, safety data, ethical considerations, and special considerations for pediatric populations.
FDA published the two draft guidances on 15 September, outlining its thinking on clinical and non-clinical studies that sponsors should conduct before submitting their premarket applications. More specifically, the agency offers recommendations on non-clinical testing, clinical study designs, and how it will evaluate risk-benefit depending on the treatment (RELATED: Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations, Regulatory Focus 5 September 2019)
For now, the guidances apply to six product codes, including intragastric implants, aspiration therapy systems, neuromodulators, and specific ingested space-occupying devices. New product codes and classification regulations may be added to the guidances in the future, FDA noted…
