The goal date passes. FDA owes a letter.

FDA runs its device review program against a defined goal, not a habit: decide 95 percent of 510(k)s within 90 FDA Days, the performance-goal target under the fee agreement funding CDRH review today. Ten FDA Days past that goal, at day 100, a specific document is required to exist whether or not the sponsor ever asks for it. FDA calls it a Missed MDUFA Decision Communication.

Not a form letter

FDA’s own guidance, Types of Communication During the Review of Medical Device Submissions, requires the notice to name the major outstanding review topics or other reasons a decision has not been reached, plus action items for FDA and for the applicant, each carrying its own estimated completion date. An Original PMA or a Panel-Track PMA Supplement gets the identical obligation on a different clock — 20 FDA Days past that submission’s own goal, rather than 510(k)’s 100. Three submission types, three deadlines, one requirement that doesn’t vary: explain the holdup in writing, specifically enough for both sides to act on it.

A meeting is offered, not owed

FDA’s current MDUFA performance-goals document lets FDA and the applicant agree to skip the teleconference the guidance otherwise anticipates, if the written correspondence already covers the outstanding issues well enough that a call would add nothing. What survives either way is the writing itself — delivered on a clock as precisely defined as the one it just missed.

A goal date that passes without a decision is not silence. It is a document FDA is required to produce, on a schedule as exact as the one it failed to keep.

Where the document doesn’t go

None of this reaches a public record. The communication is not part of a 510(k) summary, not a field in any of openFDA’s device endpoints, and not the kind of document FDA proactively posts on any schedule a Freedom of Information Act reading room would predict. It exists in the correspondence between FDA and one named sponsor, for one submission, and nowhere a second party can read it.

The practice

FDA Radar reads four public sources, and a 510(k)’s two published dates — received, decided — are the only ones that touch this record. Between those two dates, a submission can blow through its 90-day goal, generate a Missed MDUFA Decision Communication naming exactly what is wrong and who owns fixing it, and still appear in every public dataset as simply pending, indistinguishable from a submission sailing through on schedule. A long gap between the two dates is a fact anyone can see. Whether FDA has already told the sponsor, in writing, why that gap exists is not — that answer lives only in the sponsor’s own file. This is regulatory intelligence about what the public record can and cannot show, never regulatory advice about what a specific long-pending submission’s silence means.