FDA Seeks Input on Risk-Benefit Reviews for Weight Loss Devices

The FDA laid out its latest thinking on how it will handle risk-benefit reviews for weight-loss devices in a new discussion paper released ahead of planned draft guidance. Read More

FDA’s Guidance on Prostate Tissue Ablation Devices Called ‘Too Restrictive’

The FDA’s draft guidance on clinical testing for prostate tissue ablation devices is too restrictive, industry groups said in written comments to the agency. Read More

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