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FDA wire · agency

FDA: U.S. Food and Drug Administration

The federal agency that regulates drugs, medical devices, food, biologics, tobacco and cosmetics. RegPing watches its recall, safety-alert, clearance and adverse-event streams.

39 alerts · 5 urgent · 34 notice · 0 info · FDA

FDA publishes in more places than any other agency on this wire, and the places do not agree with each other. The Recalls page and its RSS feed carry only firm press releases; the weekly Enforcement Report carries every classified recall, including the ones that never got a press release, usually weeks after the recall began. openFDA exposes the same data as JSON, refreshed on a nominal weekly schedule that in practice slips by two to three weeks. RegPing reads all of them so that a recall shows up at the first sign of it and is updated when the classification lands.

What FDA publishes

  • Recalls, market withdrawals and safety alerts (firm press releases)
  • The weekly Enforcement Report: every classified recall, plus 'not yet classified' entries
  • MedWatch safety alerts for drugs, devices and biologics
  • 510(k) clearances, De Novo grants and Class I device recalls and early alerts (CDRH)
  • Warning Letters, posted after FOI redaction
  • MAUDE device adverse-event reports

Cadence. The Enforcement Report posts on Wednesdays (every report date June through August 2026 fell on a Wednesday); FDA's own pages only say 'weekly'. Recall press releases post daily. Warning Letters run about 50 a month and appear online a mean of 19 days after issuance, with a long tail. openFDA device endpoints refresh weekly in name and every two to three weeks in practice.

What to treat as urgent

  • Class I recalls: a reasonable probability of serious harm or death (21 CFR 7.3). RegPing marks these urgent.
  • Early alerts for devices, which now precede the formal recall by weeks.
  • Warning Letters naming your product category or a supplier.
  • A 'not yet classified' Enforcement Report entry for a product you sell; the class arrives later and can be worse than expected.

Quirks worth knowing

  • A recall can take three months from initiation to appearance in the Enforcement Report; GAO found 32 business days on average for Class I in FY2024.
  • openFDA never updates a recall's status after classification, and caps any query at 1,000 rows.
  • Recall numbers follow a letter-number-year pattern (Z-2914-2026 is a device, D- a drug, F- or H- food); the Event ID groups products from one recall.
  • Biologics recalls are not in openFDA at all; CBER keeps its own page and archives it after two years.
  • FDA asks that openFDA results be treated as unvalidated. RegPing does.

Subscribe at the source

Official site: fda.gov

Latest from FDA

Not legal advice. RegPing republishes and summarizes public regulator notices and links to the original. Summaries are produced with a language model and can be wrong; the regulator's text controls. Not legal advice. Consult counsel before acting.