FDA daily for Saturday, March 1, 2025
In this issue: 1 device decision and 24 label changes.
Device clearances and approvals
FDA date:FDA decided 1 510(k) and 0 PMA decisions on Sat, Feb 15.
- Sway System Sports Plus
Sway Medical, Inc. · Neurology
Label updates
FDA date:24 drug labels took effect on Sat, Feb 15. Below: those, and labels carrying a boxed warning.
- LISINOPRIL and HYDROCHLOROTHIAZIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE · GSMS, Incorporated · ORAL
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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