For Quality & Regulatory teams · Medical devices

Stop manually reading FDA portals at 7am.

FDA Signal monitors recalls, MDR spikes, warning letters, and competitor 510(k) activity for your portfolio. You get a short, source-linked briefing on what changed — not another dashboard to check.

Get startedSee a sample briefing
No procurement gate·Credit-card sign up·Built on public FDA data
—
Hover any signal to trace its predicate chain
Chain—
510(k)
Recall
MDR
Warning
01 / The work product

This is what a week looks like.

BRIEFINGS
3 / week avg
SIGNALS REVIEWED
26
SCORE THRESHOLD
≥ 60
Pattern matchSCORE 82·510(k) · COMPETITORMay 20, 2026
Sejong Medical cleared K253165 citing a competitor predicate — second time in 18 months.
A new competitor entered the LAP-iX2N device category on June 24, 2026 under product code GEI. Combined with their 2024 clearance under the same predicate strategy, this signals deliberate targeting of your portfolio. Worth tracking Sejong's pipeline for additional filings in adjacent codes.
K253165 · Product code GEI·View on FDA.gov →3 evidence sources · sourced from openFDA
ObservedSCORE 78·WARNING LETTERMay 14, 2026
Abbott received an FDA warning letter citing 21 CFR Part 820 deficiencies.
Design controls and CAPA were cited. The same finding pattern has surfaced in three other Q1 2026 letters — worth checking if your team has any open observations in those subsystems.
ObservedSCORE 71·510(k) · COMPETITORMay 14, 2026
Medtronic cleared K253656 for OsteoCool RF Ablation System 2.0 under product code GEI.
An iterative device in a product code you monitor. Worth tracking for downstream MDR activity once units enter the market.
02 / Onboarding

From signup to first briefing in under 10 minutes.

Three steps. You don't configure a thing — we pull your FDA footprint and you confirm what to watch.

STEP 01

Tell us your company.

We find your FDA footprint automatically — product codes, 510(k) history, recalls, UDI records. Your portfolio gets mapped within seconds of signup.

Your Company
GEI
FMF
LRO
NHL
DSQ
LWS
ONU
OAE
NVN
LWP
FRN
+47
STEP 02

Confirm your watchlist.

Review auto-suggested competitors based on product code overlap and predicate device history. Edit, add, or remove with one click — every change updates your daily inbox.

YouYOUMedtronicBSXStrykerAbbottSejongrecently identified
STEP 03

Read your briefings.

Daily inbox of scored signals, plus a Monday morning digest covering the week. Mark reviewed, escalated, or monitor. Nothing to maintain — the system runs itself.

SIGNAL INBOX · MON5 new
Boston Scientific recalled DBS systems
82
Sejong cleared K253165 (predicate match)
82
Abbott warning letter — 21 CFR 820
78
Medtronic K253656 (product code GEI)
71
Fresenius MDR spike — infusion pump
68
03 / Why this exists
Quality and Regulatory teams shouldn't be stitching together FDA portals, Google Alerts, and $20k procurement-gated tools to know what just happened in their product category.
/1
You found out about a competitor's 510(k) from a sales rep instead of your own monitoring.
/2
You spent a morning manually checking MAUDE for a spike that already cleared.
/3
You were asked by leadership what's happening in your product codes — and had to scramble.
/4
You looked at Basil or Cortellis and bounced off the $20k procurement process.
/5
You set up Google Alerts for "[your company] FDA recall" and called it postmarket surveillance.
/6
You watched a warning letter for an adjacent firm and thought "we have that same finding open."
04 / WHAT WE WATCH
Built on the entire public FDA dataset — and we keep watching, every day.
7
FDA data sources monitored daily
1.4M+
MDR adverse event reports indexed
180k+
510(k) clearances since 2008
24h
Maximum data lag from FDA publish
Scroll to see the chaos organize itself.
05 / Scope

We want to be very clear about what this tool is and isn't.

WHAT IT IS
  • A surveillance and intelligence tool
  • A way to reduce manual FDA monitoring
  • A starting point for Quality and Regulatory review
  • Auditable — every signal links to its FDA source
WHAT IT ISN'T
  • A replacement for your QMS, complaint, or CAPA system
  • A regulatory determination engine
  • A safety conclusion or causation analysis
  • A claim of FDA validation or affiliation
06 / Pricing

Transparent pricing. No procurement.

Pay by product codes monitored, not by seat. Unlimited workspace members on every plan.

Starter
Solo QA/RA professionals
$89/ month
or $890/yr — save 17%
  • 3 product codes monitored
  • 10 competitors tracked
  • Daily signal inbox
  • Weekly digest
Get started
MOST POPULAR
Team
QA/RA teams at OEMs
$199/ month
or $1,990/yr — save 17%
  • 15 product codes monitored
  • 50 competitors tracked
  • Daily inbox + weekly digest
  • Unlimited team members
  • PDF / PowerPoint exports
Get started
Scale
Multi-product portfolios
$449/ month
or $4,490/yr — save 17%
  • 50 product codes monitored
  • Unlimited competitors
  • Everything in Team
  • Priority support
  • Custom integration help
Get started
Consultant tier for multi-client work — talk to me
07 / Sources

Public FDA data. Refreshed daily. Documented lag.

We monitor openFDA endpoints daily and scrape the FDA warning letter index. Refresh cadence and known data lag are visible inside the product.

MAUDE adverse events
daily
Device recalls
daily
Warning letters
daily
510(k) clearances
daily
PMA records
daily
GUDID device records
weekly
Enforcement reports
daily
08 / A note

“I built this because Quality and Regulatory teams I know were either drowning in FDA portals or paying $20k+ a year for tools they couldn't try before signing a contract. There's a better middle ground — public data, credit-card pricing, a real product on day one.”

If you want to talk through what you'd actually use, my email's in the footer. I read every message.

BP
Brennan Paul
Founder · FDA Signal

Ready to stop scrolling FDA portals?

No procurement process. No long-term contract.

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FDA Signal — Regulatory intelligence for medical device teams