ARTICLE SUMMARY:
FDA finalizes weight-loss tech guide and plans new adverse event database. Excerpted from Pathways’ Picks March 18: MDR Discussions, EtO Revisions, and More Medtech Policy Updates.
The agency finalized a comprehensive guidance document on premarket requirements for devices addressing “indications associated with weight loss” March 12. The guide updates and combines two 2023 draft guidances on non-clinical and clinical expectations for the product category, which includes intragastric balloons, endoscopic devices, ingested transient products that occupy space in the stomach, neuromodulation therapies, among several other varieties. The clinical study considerations in the guide build on concepts FDA has been developing for more than a decade to support more consistent benefit-risk calculations for weight-loss devices incorporating patient preference, implant duration, and a sliding scale of different indications and adverse event risks. The final guide largely reflects what was included in the two drafts with some additional caveats on when a sham-controlled trial is needed versus a concurrent control arm and other clarifications.