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Your FDA strategy shouldn't be the part you guess on

RegReady generates a 15-page regulatory strategy report for your medical device — complete with classification, pathway analysis, testing requirements, and cost estimates. Built for SBIR applications and early-stage planning.

Get Your Report — $500 See what's included
~90s
Report delivery
15
Pages, structured
4
FDA pathways covered
The problem

FDA strategy is the most important thing founders put off the longest

💰

Consultants charge $5K–$25K

Traditional regulatory consulting is priced for Series A companies, not pre-revenue founders writing their first SBIR grant.

⏳

Weeks of back-and-forth

Even when you can afford a consultant, the regulatory assessment takes 3–6 weeks. Your grant deadline is in 10 days.

🎯

SBIR reviewers expect it

NIH and NSF reviewers score your regulatory strategy. "We'll figure it out later" costs points you can't afford to lose.

What you get

A grant-ready regulatory strategy report

Every report is device-specific — built from FDA databases, not templates. Here's what's inside.

Executive Summary p. 1
FDA Device Classification p. 3
Predicate Device Analysis p. 5
Substantial Equivalence p. 6
Testing Requirements Matrix p. 8
Risk Analysis p. 9
Timeline & Cost Estimates p. 11
Quality System Requirements p. 13
Grant-Ready Summary Language p. 14
Next Steps & Action Items p. 15

Real FDA product codes, not guesses

We search four FDA databases in parallel and rank product codes by clearance history, source diversity, and recency. Your report cites the actual regulation number your device falls under.

Predicate devices with clearance data

Named predicate devices from the 510(k) database with clearance dates, applicant companies, and a point-by-point substantial equivalence comparison tailored to your device.

Deterministic cost estimates

Cost ranges built from fixed reference data, not AI-generated numbers. Every line item traces back to a specific test or submission requirement. Totals always match.

Copy-paste grant language

The final section gives you paragraph-ready regulatory strategy text written for SBIR/STTR applications. Drop it directly into your Specific Aims or Commercialization Plan.

How it works

Three steps to a regulatory strategy

01

Describe your device

Fill out a 10-question intake form: what your device does, how it works, what clinical problem it solves. No regulatory knowledge required.

⏱ ~5 min
02

We analyze the FDA landscape

Your submission is run against live FDA databases — device classification, 510(k) clearances, PMA approvals, and registration data — to find your exact regulatory position.

⏱ ~90 sec
03

Download your report

A 15-page PDF lands in your inbox with classification, pathway, predicates, testing, costs, timeline, and grant-ready language. Ready to use immediately.

⏱ Instant delivery
Built for

Founders who need a regulatory strategy yesterday

SBIR Applicant

Writing your first NIH or NSF grant

You need a credible regulatory strategy section but don't have $15K for a consultant or 6 weeks to wait. Your grant deadline is non-negotiable.

Technical Founder

You built the science — now what?

You know your assay or device works. You don't know whether it's a 510(k), De Novo, or PMA — or what the difference means for your timeline and funding.

Incubator / Accelerator

Equipping your cohort with regulatory clarity

Your medtech teams need regulatory positioning for demo day and investor conversations. Individual consulting doesn't scale. RegReady does.

Pricing

One device. One report. One price.

No subscriptions, no retainers, no scope creep. Pay once, get your regulatory strategy.

$500 per report

Complete FDA regulatory strategy report for one medical device

  • ✓ FDA device classification with product code and regulation number
  • ✓ Predicate device identification and substantial equivalence analysis
  • ✓ Testing requirements matrix (analytical, biocompatibility, software, clinical)
  • ✓ Risk analysis mapped to your device's specific capabilities
  • ✓ Cost estimates and regulatory timeline
  • ✓ Quality system requirements summary
  • ✓ Grant-ready regulatory strategy language (SBIR/STTR)
  • ✓ 15-page PDF delivered to your inbox
Start Your Report →

You'll fill out a short intake form, then complete payment. Report delivered via email within minutes.

Questions

Common questions

How is this different from ChatGPT?
RegReady isn't a chatbot. It's a structured pipeline that searches four live FDA databases, scores product codes by clearance history, and generates a formatted PDF with deterministic cost calculations. The cost table is built from fixed reference data — not generated text. Every product code, regulation number, and predicate device in your report comes from FDA records.
Can this replace a regulatory consultant?
For early-stage planning and grant applications, yes — that's exactly what it's designed for. For a formal pre-submission meeting or an actual 510(k) filing, you'll still need regulatory counsel. RegReady gives you the strategic foundation to have those conversations informed, not cold.
What if my device is truly novel?
If our classification engine can't confidently map your device to an existing FDA product code, we'll flag it for manual review and reach out directly. You won't receive a low-confidence report — you'll get a human follow-up. Novel devices may require a De Novo pathway, and we'll help you understand what that means.
What kind of devices does RegReady cover?
Any FDA-regulated medical device: in vitro diagnostics, software as a medical device (SaMD), implantables, surgical instruments, wearable monitors, combination products, and more. The classification engine handles Class I through Class III across all device categories.
How long does the report take?
About 90 seconds from form submission to PDF delivery. The report is generated automatically using live FDA data — there's no queue, no waiting for a human reviewer.
Can I use this for my SBIR/STTR grant?
Yes — this is the primary use case. The report includes a dedicated section with paragraph-ready regulatory strategy language formatted for NIH and NSF grant applications. Drop it into your Specific Aims, Research Strategy, or Commercialization Plan.