FDA daily

FDA daily for Saturday, February 10, 2024

In this issue: 1 device decision and 16 label changes.

Device clearances and approvals

FDA date:

FDA decided 1 510(k) and 0 PMA decisions on Sat, Jan 27.

  • Epilaser Pro

    Epilady 2000, LLC · General, Plastic Surgery

    K233224Substantially EquivalentTraditional
Browse device clearances and approvals in FDA data →

Label updates

FDA date:

16 drug labels took effect on Sat, Jan 27. Below: those, and labels carrying a boxed warning.

  • GENTAMICIN SULFATE

    GENTAMICIN SULFATE · HF Acquisition Co LLC, DBA HealthFirst · INTRAMUSCULAR, INTRAVENOUS

    Boxed warningHUMAN PRESCRIPTION DRUG
Browse label updates in FDA data →

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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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.