For pharma RA, drug-shortage teams, food-safety, and biologics

Track FDA rulemaking across drug, food, biologics, and devices.
One pipeline, scored for substance.

FDA touches every regulated industry from biologics to dietary supplements. The Federal Register publishes a constant stream of FDA notices — most procedural, a few that materially change manufacturing, labeling, or filing obligations. regflow scores each one 1-5 and routes only the substantive ones to your team.

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§ 01 A real alert from today's run

M4 Federal Register

Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring

FDA classifies rigid sterilization containers with electronic monitoring as class II medical devices subject to special controls. The rule codifies device-specific controls intended to provide reasonable assurance of safety and effectiveness and establishes the regulatory pathway for this device type.

The rule creates codified special controls for a specific medical device type, which manufacturers must satisfy for class II compliance and marketing submissions. This changes the regulatory classification and compliance expectations for rigid sterilization containers with electronic monitoring.

  • medical-device-classification
  • class-ii-special-controls
  • sterilization-containers
  • hospital-sterilization-equipment
  • fda-device-regulation
https://regflow.us/rss/fda-medical-device-classifications 7 matches in the last 30 days · view all

§ 02 How it works for you

STEP 01

Pick your watch

Start from the FDA regulatory feed preset or build a custom watchlist around your HTS codes, agency targets, or product line.

STEP 02

Get scored alerts

Every matching Federal Register doc carries a materiality score and a one-paragraph rationale. M3+ by default — no procedural noise.

STEP 03

Subscribe how you work

RSS today. Email digest and Slack/Teams webhooks ship with the Q3 milestone. One feed per watch.

Founding-customer waitlist

50 founding seats at $79/mo locked for 24 months. Reply within 24 hours. No card, no commitment — we'll send you the live feed and let it speak for itself.

Pro · founding 50
$79/mo · locked 24mo

Founding pricing

  • 5 watchlists
  • RSS + JSON + Email + Webhook
  • M2+ alerts, custom thresholds
  • Discord / Slack delivery
  • 30-day free trial

§ Reserve a seat

§ 03 Common questions

Do you cover all FDA centers (CDER, CBER, CDRH, CFSAN, etc.)?

Today: every Federal Register notice from any FDA center. Coming Q3 2026: direct integrations with FDA structured databases (510(k), Orange Book, drug-shortage list, food-safety updates).

Can I filter to drug vs food vs device alerts?

Yes. Use topic tags like fda-device-clearance, drug-labeling-changes, food-safety-rule, or biologics-licensure as filters. Custom watchlists on Pro let you combine multiple topic tags with keyword scoping.

How does this compare to FDA Law Blog or Hyman Phelps newsletters?

Those are excellent analyst commentary, weekly, with editorial lag. regflow is daily, machine-fast, scored for triage. The two complement each other — most Pro customers use regflow for triage and analyst newsletters for deep dives.