Features
The guidance tells you the rule. The letters tell you the bar.
Deficiency patterns are signal
What FDA is catching today is what you will be asked about tomorrow. Searching the actual deficiency letters is how you find out what reviewers reject, not just what the guidance leaves open to interpretation.
Tribal knowledge does not scale
A searchable, source-attributed corpus beats relying on one senior expert's memory. Every question and its answer is kept, so the reasoning survives when that person is on PTO or has moved on.
It tells you when it does not know
Answers may only draw on the documents retrieved, never on outside knowledge. When the library holds nothing that bears on your question, the answer says so instead of filling the gap with something plausible.
How we work with your team
Ask, read the evidence, keep the answer.
There is no query syntax to learn and no result list to sift. You ask the question you would have asked a consultant, and what comes back shows its work.
Ask the question you would ask a consultant.
Search across FDA cybersecurity guidance, deficiency patterns, and regulatory decisions by asking a question rather than guessing at keywords. If you are not sure where to start, the suggested questions open on the things teams most often need to know.
Regulatory Intelligence
What are the most common cybersecurity deficiencies in 510(k) submissions?Suggested questions
Every answer quotes what it relied on.
Answers come back in three parts: a summary, the requirements that apply, and the evidence itself, quoted from the source documents with each passage credited to the document it came from. You can judge the reasoning yourself rather than trusting a paraphrase.
Search results
Summary
Applicable requirements
Evidence from regulatory documentsEvery question you've asked stays searchable.
Answers are not disposable. Each query and the evidence behind it is kept and can be reopened later, so the case a colleague built for one submission is still there for the next one. That record is what turns one expert's research into something the whole team can draw on.
Past queries
2h agoYesterday3d ago1w ago
What you get
What lands in your hands.
Semantic regulatory search
- Meaning-based search across FDA guidance and deficiency letters, so a question finds the passage that answers it even when it shares none of its words.
Answers with their evidence attached
- Three to five verbatim quotations behind every answer, each credited to the document it came from, with the requirements that apply listed alongside.
A corpus of real FDA decisions
- Curated by a team that includes former FDA reviewers and authors of the guidance itself, so what you search is how the rule gets enforced rather than only the text of the rule.
A kept, de-identified record
- Past queries and their answers stay available to your team. The library itself is staff-curated and never contains customer submissions, and identifying details are stripped from the source documents it does hold.