How to use this

The keys, the words, and what each figure means.

The flow

1. 1Paste — your device description or a draft 510(k) — or drop the folder. Or start from a K-number you already hold.
2. 2Read the verdict — it says whether you can file, what that means, and the one thing to do first.
3. 3Answer one question — if the system could not settle a fact from your text, it asks the single one that changes the most — and tells you what changes.
4. 4Check each answer — every card opens with the answer, then its basis, what it read, how often that kind of answer is wrong, and what would move it.
5. 5Correct where you disagree — on any row. A correction is marked yours, kept on the record, can be undone, and is offered back to you on later dossiers — never applied on its own, never shared across sponsors.
6. 6Review and endorse — a qualified person records the review. Export the Word file, the documents, or the eSTAR data.

Keys

⌘K / Ctrl+K or ?

open the palette — go to any section, export, copy the link

⌘ / Ctrl + Enter

analyze the device text

/

open the intake and focus the device text

a

focus the first answer

j / k

next / previous section

Esc

close

The words

FDA’s terms, as the page uses them. Each is also defined where it first appears.

predicate

A device FDA has already cleared that yours is compared to. A 510(k) is cleared by showing your device is substantially equivalent to it.

intended use

What the device is for, in general — the purpose. FDA compares it with the predicate’s first; if it differs, the 510(k) route is closed.

indications for use

The specific conditions, patients and settings the device is meant for. Must stay within the predicate’s intended use.

substantial equivalence

The 510(k) test: same intended use as the predicate, and either the same technology or differences that raise no new question of safety or effectiveness.

Refuse-to-Accept

FDA’s 15-day completeness screen. A submission missing any checklist element is refused before review starts.

De Novo

The route for a device with no predicate: FDA creates a new classification. Slower and costlier than a 510(k).

Special 510(k)

A faster 510(k) for a change to a device you already had cleared, when the change can be checked by design controls.

Abbreviated 510(k)

A 510(k) that relies on declared conformity to FDA-recognized standards or guidance instead of full test reports.

product code

FDA’s three-letter label for a device type. It fixes the regulation, the class and what FDA expects.

regulation

The section of 21 CFR that defines the device type and its class — what the product code points to.

recognized standard

A consensus standard (ISO, IEC, ASTM…) FDA has formally recognized. Declaring conformity to the recognized edition carries weight; an older edition may not.

special controls

Extra requirements FDA attaches to a Class II device type — labeling, testing, performance — that a submission must address.

Pre-Submission

A Q-Sub: a written request for FDA’s feedback before filing. Optional; advisable when the route or the testing is uncertain.

513(i)(2)

The section of the FD&C Act that bars a predicate: a device that was removed from the market, or found misbranded or adulterated, cannot be one.

AI letter

FDA’s Additional Information request during review. The clock stops until you answer; the questions are confidential to the sponsor.

NSE

Not substantially equivalent — FDA’s refusal of a 510(k). The device cannot be marketed on it.

eSTAR

FDA’s electronic submission template. Every 510(k) is filed in it; the fields are fixed.

pre-dates

Cleared before your submission date — a predicate must have been legally marketed before you file.

§524B

The cybersecurity section of the FD&C Act: a device with software that can connect needs a cyber package (SBOM, threat model, patch plan).

PCCP

A predetermined change control plan — for AI/ML devices, the future changes FDA clears in advance.

MAUDE

FDA’s adverse-event reports database. Counts of reports, not rates of harm.