An Additional Information letter freezes your submission, answer in time or start over. MSI gets your response FDA-ready in a fraction of the window, drafted with former reviewers in the language the agency is waiting to read.
Beat your deadline →Every deficiency is parsed and mapped to what FDA is really asking, with the guidance and precedent behind it surfaced alongside.
Former FDA CDRH reviewers work your response with you, not a ticket queue, not generic templates.
Semantic search across actual FDA deficiency letters means your response reflects what has closed findings like yours before.
Respond well, within the window, or risk withdrawal and a restart. The letter sets the deadline; this is how you hit it.
A vague or incomplete response earns another hold letter and another quarter lost. Answering precisely the first time is the whole game.
FDA is reviewing submissions with new tooling of its own, and the level of rigor that cleared a finding last year may not clear it now. Your response has to meet the standard the agency is applying today, not the one it used to.
Upload the AINN or hold letter along with your submission package. No reformatting.
MSI breaks the letter into discrete findings and drafts structured responses, citing the relevant guidance and prior deficiency precedent.
Former FDA reviewers verify each response would actually close the finding, before it goes back to FDA.
AI-assisted drafting and tracking of regulatory correspondence, organized finding by finding so nothing in the letter goes unanswered.
Semantic search across FDA guidance and real deficiency letters, with suggested queries, highlighting, and source attribution.
Ask questions of FDA guidance and your own evidence in plain language while you draft, with answers you can trace back to source.
Every response versioned and tracked, so nothing falls through the cracks between rounds of review.
Most responses guess at what FDA wants. MSI grounds yours in what FDA actually issues and accepts, built on proprietary data about what the agency is catching and requiring, by a team that includes former FDA CDRH reviewers and authors of the guidance itself. Automation for the draft, reviewers for the judgment.
Former FDA CDRH reviewers · AINN & hold letter response · 510(k) / De Novo / PMA · Deficiency-letter intelligence · Section 524B aligned
One working session on your actual letter. The findings decoded, the response mapped, the people who've closed them before.
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