If you work in medical device regulation, you’ve likely felt the frustration: you know the FDA has approved similar devices, issued guidance, and published summaries — and yet you spend hours, sometimes days, trying to find the information you need.

That’s because while the FDA’s playbook is technically public, it was never designed to be searchable, strategic, or user-friendly.

At Agent Astro, we’re solving that problem — by turning thousands of static documents into an intelligent, searchable knowledge base for regulatory professionals. Here’s how we do it — and why it matters more than ever.

The FDA Shares Almost Everything — That’s the Opportunity

The U.S. Food and Drug Administration publishes an extraordinary amount of information related to device approvals and regulatory processes. This includes:

• 510(k), De Novo, and PMA decision summaries
• Product classification codes and device types
• Guidance documents and advisory notices
• Special controls and risk mitigations
• Intended use statements and labelled indications
• Performance testing expectations
• Historical review timelines

In short: the regulatory playbook is out in the open. Every decision, precedent, and pattern is available — in theory.

The Problem: It’s Buried in PDFs and Inconsistent Formats

While the information is public, it’s also fragmented, inconsistently structured, and scattered across multiple databases. Searching for relevant data typically means:

• Manually sifting through 10–20-page 510(k) summaries
• Guessing at keywords and product codes
• Repeating searches every time a new device is in development
• Copy-pasting findings into spreadsheets or slide decks

Even experienced regulatory professionals often start from scratch — not because they don’t know what to do, but because they don’t have tools that make the public data usable.

The Insight: The Answers Are Already Out There — Hidden in Plain Sight

Strong submissions don’t need to reinvent the wheel. The language, structure, and rationale that succeeded in the past can inform smarter strategies today.

That’s the core idea behind Agent Astro:

If the regulatory playbook is already written, let’s make it accessible — and actionable.

Every 510(k) cleared, every De Novo granted, every PMA approved holds insights about what works:

• Which predicates were accepted — and why
• How “substantial equivalence” was phrased
• What testing strategies passed review
• What claims were permitted in the indications for use

But until now, there was no fast, reliable way to mine those insights — at scale.

From Data Chaos to Clarity: How Agent Astro Makes the FDA Playbook Usable

Public FDA Data (The Problem)

Agent Astro (The Engine)

Regulatory Outcomes (The Result)

- Thousands of 510(k), De Novo, and PMA summaries

- AI-powered parsing and indexing

- Fast predicate identification

- Inconsistent formats and terminology

- Retrieval-Augmented Generation (RAG) connects questions to context

- Precedent-based justifications ready for use

- Manual searches, slow PDF reviews

- Structured comparison of devices, pathways, and language

- More confident, strategic submissions

- No easy way to track patterns or reuse insight

- Centralised platform for discovery and benchmarking

- Reduced time-to-submission and fewer review cycles

- Valuable data hiding in plain sight

- Intelligent surfacing of equivalence logic and FDA language patterns

- Regulatory strategy becomes a competitive advantage

How Agent Astro Makes the FDA Playbook Searchable

Here’s how we turn scattered regulatory documents into strategic intelligence:

🔎 AI-Powered Indexing of FDA Submissions

We parse and structure thousands of summaries, mapping key elements like device class, intended use, performance testing, and equivalence language — turning unstructured PDFs into searchable data.

🧠 Retrieval-Augmented Generation (RAG)

Agent Astro uses RAG to pair verified regulatory content with natural language prompts. That means you can ask a question and get not just an answer — but a citation from a real FDA decision to back it up.

🧩 Predicate Discovery, Reimagined

Our system cross-references devices by characteristics, not just keywords — allowing you to discover predicate options and similar devices based on real-world relevance, not guesswork.

🗂 Submission Intelligence, On Demand

We surface submission structure patterns: how testing was presented, how equivalence was justified, what performance benchmarks were used — so you can model success, not chase it.

What Happens When the Playbook Becomes Searchable?

When regulatory teams can access this information easily, the shift is immediate and dramatic:

• Research that once took hours happens in minutes
• Submissions become smarter, faster, and more reviewer-friendly
• Precedent isn’t a last-minute add-on — it’s the foundation of strategy

This doesn’t just save time. It builds confidence. It reduces review cycles. And it helps level the playing field for smaller companies competing with resource-heavy giants.

Regulatory Intelligence, Finally Within Reach

We didn’t build Agent Astro to replace regulatory professionals — we built it to empower them. You still lead the strategy, the judgement calls, and the submission. We just give you faster, better access to the data that matters most.

The FDA’s knowledge is written in public. You just need the right lens to read it.