FDA Regulatory Intelligence

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critical FDA
update again.

RegPatrol monitors FDA guidance, recalls, and safety communications — and delivers actionable intelligence for your medical device directly to your inbox. Weekly. No noise.

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digest@regpatrol.com · weekly

3 updates this week

Guidance

FDA finalises PCCP requirements for AI/ML-based SaMD submissions

Action: Review SBOM documentation before next 510(k)

Recall

Class II recall — insulin pump alert threshold logic defect

Action: Assess similar threshold logic in your device software

Safety

FDA updates Q-submission turnaround commitments FY2026

Action: Adjust pre-submission timelines in regulatory plan

Monitoring

●FDA Guidance Documents ●510(k) Database ●Medical Device Recalls ●CDRH Policy Updates ●Safety Communications ●De Novo Classifications ●PMA Approvals ●Early Alerts ●FDA Guidance Documents ●510(k) Database ●Medical Device Recalls ●CDRH Policy Updates ●Safety Communications ●De Novo Classifications ●PMA Approvals ●Early Alerts

The problem

FDA publishes hundreds of updates
a year. Most startups miss the ones that matter.

You can't watch everything

FDA.gov has dozens of sections updated daily. Guidance documents, recalls, safety alerts, policy changes — no founder or lean RA team can manually track all of it alongside building a product.

Missing an update is expensive

A missed guidance update can invalidate your 510(k) strategy. A missed recall trend can surface in an FDA inspection. The downstream cost of not knowing is never zero — and rarely small.

Enterprise tools aren't built for you

Platforms like Veeva and IQVIA are built for 500-person regulatory teams at Medtronic. Complex, expensive, and completely overkill for a lean medtech startup that just needs to stay informed.

How it works

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STEP 01

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Set your device profile

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STEP 02

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We monitor FDA daily

Our system watches FDA guidance, 510(k) database, recalls, and CDRH policy pages every single day — automatically.

STEP 03

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Expert interpretation

Only updates relevant to your device type get through. Each one is interpreted by a regulatory expert — not just forwarded raw.

STEP 04

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Clean digest, every week

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What's included

Everything a lean RA team actually needs.

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Weekly FDA digest

Curated updates from guidance docs, recalls, 510(k) activity and CDRH policy — filtered to your device type.

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Plain-language summaries

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Action items per alert

Specific next steps written by a medical device regulatory expert — not AI-generated boilerplate.

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Direct source links

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Searchable alert archive

Full history of past alerts. Useful for audit readiness, regulatory strategy, and onboarding new RA hires.

FROMdigest@regpatrol.com

SUBJ3 FDA updates relevant to your device

📋 What changed

FDA issued final guidance on predetermined change control plans (PCCPs) for AI/ML-based SaMD, clarifying which post-market model changes require a new premarket submission.

🎯 Who it affects

Class II SaMD companies using machine learning, especially those planning post-market model updates without a new 510(k) submission.

⚡ What to do

Review your PCCP documentation against new examples in Section 4.2
Flag planned model retraining cycles that may require pre-notification
Update your regulatory strategy doc before next Q-submission

🔗 Source

fda.gov/medical-devices/software-medical-device-samd/pccp-guidance

Pricing

Less than one hour of a consultant's time. Every month.

Essential

Starter

^$49

per month · billed monthly

Weekly FDA digest (1 device profile)
Plain-language expert summaries
Action items per alert
Direct FDA source links
Email delivery every Monday

Professional

Pro

^$99

per month · billed monthly

Everything in Starter
Up to 3 device profiles
Instant alerts for critical updates
Searchable alert archive
Monthly 30-min regulatory briefing call

Early feedback

What medtech teams are saying.

★★★★★

"We caught a guidance update that would have invalidated our 510(k) strategy — two weeks before our pre-sub. Worth every penny."

Sarah L.

Head of RA · Class II SaMD startup

★★★★★

"I use RegPatrol with all my clients now. The action items save me an hour of prep per client call. It's like having a junior RA on retainer."

Marcus R.

Independent RA Consultant

★★★★★

"As a non-regulatory founder, this is the first tool that actually tells me what to do instead of just dumping a document on me."

Anika T.

CEO · Wearable diagnostics startup

Never miss a critical FDA update again.

FDA publishes hundreds of updatesa year. Most startups miss the ones that matter.

From FDA source to your inboxin under 24 hours.

Everything a lean RA team actually needs.

Less than one hour of a consultant's time. Every month.

What medtech teams are saying.

Start your free 30-daytrial today.

Never miss a
critical FDA
update again.

FDA publishes hundreds of updates
a year. Most startups miss the ones that matter.

From FDA source to your inbox
in under 24 hours.

Start your free 30-day
trial today.