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510(k) Submission Consistency Review

510K submission review that finds each fact the draft states more than once, compares every place it appears, and writes each disagreement the way a reviewer would, before the file is sent.

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Follow number 6, the sterilization method, to a strike ↓
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The problem

One fact in six places, owned by four people, read by none of them twice

A premarket file for a powered stapler states the articulation angle in the device description, the instructions for use, the drawing and the predicate comparison. The sterilization method sits in the sterility section, the label artwork and the validation report. Different people type those answers at different times.

Teams cross-read in the last week before sending, section by section, so a fact that lives in two sections owned by two people slips through. The reviewer finds it, writes it up, and the whole submission goes on hold while the company answers.

Built forRegulatory affairs specialistsRegulatory affairs managersDesign quality engineersLabeling specialists

The Problem Today

A premarket file states each fact many times, and when two places disagree the reviewer writes it up and the review stops.

63–68%
asked for more on the first review, per a published summary our estimate
180 days
to answer that request, or the file is treated as terminated published

Cross-read by hand today

  • Sections
  • Labels
  • Test data
  • Risk file
  • One fact, two ownersEach section is checked by its owner, never across
  • The last weekThe cross-read waits until the file is nearly done

The Solution

  1. Read the whole fileThe draft eSTAR, its attachments and the design records behind them
  2. Compare each placeEach repeated fact checked against every other place that states it
  3. Write it as a reviewer wouldEach mismatch drafted as a numbered deficiency, both pages cited
  4. Fix, re-read, acceptThe owner corrects the source and the agents re-read each place of it

Built-in controls

  • Nobody accepts their own fix
  • Agents never rule, sign or submit
  • The manager signs only when nothing is open

What You Get

Regulatory affairs sends each file knowing it agrees with itself, place by place.

1,600 h
of cross-reading a year back at a maker filing forty a year our estimate
  • Questions closed earlyEvery item cites two pages and names whoever fixes it
  • A fix reaches every placeOne correction cannot leave another page behind
  • A record to showEach ruling, fix and signature in one export
Draft 7, one morning

A 510K submission review of draft 7: the label that says irradiation

A powered stapler with a new jaw-gap gauge, a cleared predicate, and a draft that arrived at 07:40. By 08:19 the letter holds fourteen items.

demoStapler, predicate, maker, staff and figures on these screens all come from a made-up sample world.

  1. 0108:19

    386 facts repeat in 914 places across 2,202 pages, and 14 disagree

    Regulatory affairs specialist

    Draft 7 sits on the left by section, each with the deficiency numbers that point into it. On the right, a letterhead marked draft and never sent holds 14 numbered deficiencies, 11 major and 3 minor. 369 facts agree in every place, and 3 wait for her because one of their places is a scanned image.

  2. 0208:20

    Number 6: the sterility section says ethylene oxide, the label irradiation

    Regulatory affairs specialist

    The item puts the sterility section beside the reload label artwork, attachment 11-3, page 1. Below them sits a third document the agents propose as the source of truth: the sterilization validation report, which is outside the submission. Their confidence is 0.99, and the rule buttons stay grey until she has opened each page herself.

  3. 0308:21

    STERILE R on the reload label, with a two-year use-by beside it

    Regulatory affairs specialist

    The label page opens with the line in question marked: STERILE R, sterilized using irradiation. The rest of the artwork reads as expected, single use and prescription only, six reload codes. A page counts as read only once it has stayed open two and a half seconds, so a glance at the thumbnail cannot release the ruling.

  4. 0408:22

    Page 3 of the validation report: 100% ethylene oxide, half cycle 2 h

    Regulatory affairs specialist

    The validation report is one of 5 records the agents read behind the eSTAR, 342 pages the reviewer will never see. Page 3 names the process, the load and the sterility assurance level of 10⁻⁶. She now has both places and the record that decides between them, all opened in her own name.

  5. 0508:24

    She rules place A right, and the label goes to labeling for 2 days

    Regulatory affairs specialist

    She signs the ruling with her own password. The next step card names the labeling specialist, the attachment and the page, due in 2 business days. Had she ruled for the label instead, against the cited report, the solution would ask for a reason in full words and wait for the regulatory affairs manager to read it.

  6. 0608:28

    The labeling specialist signs STERILE EO onto the label draft as its author

    Labeling specialist

    Signed in as herself, she opens the label, applies the corrected wording the agents drafted from the validation report, and signs as author: STERILE EO, sterilized using ethylene oxide, symbol 5.2.3. Two minutes later the re-checker has read all 6 places of the fact again, and they agree.

  7. 0708:32

    The accept button counts only after she opens the corrected label

    Regulatory affairs specialist

    Back in her own seat, she opens the corrected label. The new line is marked on the page, so she checks the wording the label will carry, as it will print. An edited correction would show as not compared, for a person to read, and would stay amber until someone did.

  8. 0808:33

    Number 6 strikes through, and the letter reads 13 open

    Regulatory affairs specialist

    Number 6 sits in the letter with a line through it: fixed in the revision B label draft, accepted in her name at 08:33. Thirteen others wait with their owners: seven with her, three with labeling and three with design quality, all due in the same 2 business days.

  9. 0908:40

    The 510K submission review report stays locked: 13 open, 3 pages held

    Regulatory affairs manager

    The consistency report lists what blocks his signature: the open deficiencies, three scanned pages no person has read yet, and 12 of 369 agreed facts drawn at random for him to open. A reopened item or a new draft clears the signature. Sending the eSTAR is his own decision; the solution does not submit.

Four places where draft 7 contradicted itself, owned by different people

Each one had passed the section owner's own read.

Same as predicate, except it is not

The comparison table calls the jaw-gap gauge the same as the predicate. The predicate's own summary says it has no jaw-gap display.

Tested firmware 3.0.0, declared 3.0.2

The firing report used 30 handles on 3.0.0. The software section and device description name 3.0.2, so regression evidence is owed.

No data interface, apart from the service port

The cybersecurity section says there is none. The device description shows a USB-C port under the handle label, used to load firmware.

Implanted staples filed as limited contact

Biocompatibility says 24 hours or less. The biological evaluation report treats the staples as a permanent implant.

demoSample data, from the working solution.

Number 7: a three-year shelf life the aging data cannot carry

The shelf life section claims 3 years. Against it, the aging report ran 92 days at 55 °C, and the sum falls short.

CheckValue
Shelf life claimed in the eSTAR3 years
Aging factor at 55 °C against 25 °C8
Days at 55 °C for 2 years, 730 days divided by 891.25, run as 92
Days at 55 °C for 3 years, 1,095 divided by 8137
Use-by date on the label2 years

demoSample data, from the working solution. The aging report and the label agree on two years. The eSTAR answer is the place that moves.

Around the letter

The facts, the predicate and the intake behind each eSTAR review

The rest of what regulatory affairs reads before a draft goes out, and after a request comes back.

386 repeated factsEach fact the file states more than once, by family, with its places and state. Open any fact to check an agreement yourself.
Predicate comparisonThe substantial equivalence table row by row against the predicate's own summary. Rows that claim same where sources differ point at their deficiency.
Sections and structureEach section's answers, attachments and pages, with the structure checks: attachments present, page references holding, standards declared against those tested.
What came in46 attachments, 5 records from outside the submission, and 3 scanned places a person must read. Nothing is changed in the systems they came from.
After a request comes backOn another submission, the response narrows a claim from 7 mm to 5 mm. The re-check finds 3 places still saying 7 mm.
Audit trailFrom the draft's arrival at 07:40 to her ruling at 08:24, people and agents in one list. Each signature shows what it meant and which session made it.

demoSample data, from the working solution.

Five people, and the one who fixes is never the one who accepts

Each opens a different page first.

Regulatory affairs specialist
Sees
The letter, both places of each item and the proposed source
Signs
Rules which place is right and accepts other people's fixes
Regulatory affairs manager
Sees
Rulings against the evidence, dismissals and a random sample of agreed facts
Signs
Accepts the specialist's own fixes and signs the consistency report
Labeling specialist
Sees
Label and instructions items, with wording drafted from the record
Signs
Corrects the label as its author
Design quality engineer
Sees
Firmware, electrical and test report items
Signs
Attaches regression and addendum evidence
R&D program manager
Sees
The letter and the report, to watch the send date
Signs
Nothing: reads only
Who reads the draft

Seven agents cross-read the file; none decides which place is right

They read, compare and write. People rule, fix, accept and send.

Section reader

Reads each section, its answers and attachments, page by page.

  • Never edits the eSTAR or answers a question in it
Fact extractor

Finds each fact stated in more than one place, with its page and passage.

  • Never reads a value off a scanned image; a person does
Cross-reader

Compares each place of a fact with every other: values, units, editions, wording.

  • Never decides which place is right
Predicate comparator

Checks each comparison row against the predicate's summary and the new device's records.

  • Never chooses a predicate or argues equivalence
Structure checker

Checks attachments, page references and standards declared against those tested.

  • Never changes an eSTAR answer
Deficiency writer

Writes each mismatch in four parts, cites both places and proposes the source of truth.

  • Never sends anything outside the company
Re-checker

After a fix, reads each place of that fact again; after a response, each changed fact.

  • Never strikes an item through; a person accepts

What regulatory affairs keeps in its own hands before a file goes out

These stay with named people, whatever the agents propose.

Sending the submissionThe manager decides when the eSTAR goes. The draft letter is internal and never leaves the company.
A ruling against the cited recordIt needs a written reason and the manager, who reads the exact words before it counts.
Dismissing a deficiencyA proposal to drop one waits for the manager to countersign or send it back.
Accepting your own fixSomeone else opens the corrected place and accepts it.
Scanned pagesA person opens the image and types what it says. It shows as read by a person rather than compared.
Complaint and adverse event recordsNo section the agents read holds them. If a submission needed one, it would arrive as one signed input from complaint handling, referenced and left unopened.

What regulatory specialists ask before a 510K submission review

What is a 510K submission review?

A 510K submission review reads a draft before it is sent and checks it against itself. This one finds each fact the eSTAR and its design records state more than once, compares every place, and writes each mismatch as a numbered deficiency citing both pages, for regulatory affairs to rule on and close.

Does it assemble the eSTAR or run the technical screening?

No. It starts once a draft exists. Building the submission and screening it for completeness is separate work; this reads what has been built the way a reviewer would.

Why read records that are not attached?

Because the facts in the eSTAR come from them. The risk file, the software hazard analysis, the material specification, the validation report and the drawings often decide which of two places is right.

What happens after one place is corrected?

The re-checker reads every place of that fact again, so a fix in one section cannot leave a stale value in another. A different person then opens the corrected page and accepts it.

Can it check our response to a request for more information?

Yes. Each fact the response changes is read in every other place of the original file, and any place still stating the old value goes to its owner as a fix before the response is signed.

Does it send anything to the agency?

No. Agents never submit, sign, accept or dismiss. The letter is a draft for the company's own eyes, and the regulatory affairs manager decides when the file goes.

Will it look at complaint or adverse event data on the predicate?

No. It does not search those databases and reads no such records. Questions about something that happened to a device or a person are sent to complaint handling.

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Bring draft seven of your next file
and the records behind it.

We will cross-read each repeated fact and show you the letter before anyone else writes it.

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