news report
CMS Proposes RAPID Medicare Device Path
The voluntary proposal would coordinate Medicare coverage reviews with FDA authorization for selected breakthrough devices, with final coverage goals of 60 or 90 days.
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Food and Drug Administration
explainer
DEA Could Put Concentrated 7-OH in Schedule I Within Days. Here’s What the Record Shows
The action is not yet in force and does not formally cover ordinary kratom leaf below the proposed threshold. The evidence shows real opioid risks, major data gaps and a narrow public process that closed after July 31.
news report
FDA Reopens BHT Food-Additive Comment Period Through Aug. 31
The agency is seeking additional information for its post-market reassessment and says it has not reached a new safety conclusion about the preservative.
news report
FDA Proposes Class II Path for 3D Breast Scans
The agency would move digital breast tomosynthesis systems from premarket approval to special controls and 510(k) review, while keeping dedicated breast CT in Class III.
news report
FDA Updates Fresh-Cut Produce Safety Guide
The final nonbinding guide adds antimicrobial, supply-chain and time-temperature examples while clarifying which ready-to-eat produce it covers.