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Catalog · Submissions
510(k) RTA Readiness Workbook
Score your 510(k) against FDA's Refuse-to-Accept criteria before intake does it for you — section by section, with an evidence cell for every claim.
- Find the gaps that bounce submissions while they are still cheap to fix
- Walk into intake with an evidence citation for every RTA row, not a tick
- Hand reviewers and consultants one shared, checkable readiness picture
Built like the working documents we write about
Section-by-section RTA map
Every acceptance-review row from the current policy, one verifiable claim per line — no compound checkboxes.
Objective-evidence column
Each row demands a document number, report ID or page reference. An empty cell is the safety mechanism.
Readiness rollup
A scored summary tab that turns row-level answers into a section-by-section readiness picture for the whole file.
Aging & owner fields
Assign every open gap an owner and a date, so readiness review runs like a tracker, not a one-off audit.
Source-revision ledger
The workbook states the RTA policy revision it was built against, visibly, so staleness is a fact you can check.
Worked example tab
A filled-in specimen section showing what good evidence entries actually look like.
Exactly what you get
No surprises at download time — the format, the scope, and the license, stated up front.
- Format
- Microsoft Excel (.xlsx) — no macros, works in Google Sheets
- Length
- 7 tabs · ~140 checklist rows
- Mapped to
- FDA Refuse-to-Accept policy for 510(k)s, section by section
- Delivery
- Instant download after checkout, with a re-download link on your receipt
- Updates
- Revised when the source moves; buyers get the new revision by email, free
- License
- One purchase covers your team at one company site
Check our work
Every row in this workbook cites the RTA policy section it implements, and the workbook states the revision it was built against — the same rules the whole shelf follows. Read the craft behind it: what makes a checklist worth trusting and how we watch a source for movement.
Take the workbook to work today.
$49 once, yours immediately — and revised for free when the source moves.