This is the course’s last stop. Ten questions, two from each lesson, in the order the pathway runs — doctrine, predicate, type, file, review. Pick an answer and it locks: the explanation appears immediately, the right answer is shown when you miss, and your score arrives with the last question. Nothing is recorded and nothing is sent anywhere — retake it as often as you like. If you have not taken the course yet, start at the syllabus; the quiz will still be here.
Course quiz · 10 questions
Did the file clear?
Two questions from each lesson, in the order the pathway runs. The score arrives with the last answer.
-
1A 510(k) that succeeds ends in what?
A 510(k) is a premarket notification, not an approval. It ends in clearance — a finding of substantial equivalence under section 513(i) of the FD&C Act — and silence permits nothing: you market when the SE letter arrives.
-
2Substantial equivalence means the new device has…
Both halves matter, in that order: intended use first, technology second — and where the characteristics differ, the differences must raise no different questions of safety and effectiveness.
-
3Which of these devices can serve as a predicate?
A predicate must be legally marketed: on the market before the 1976 amendments, cleared through a 510(k), granted De Novo classification, or reclassified down from Class III. PMA-approved and foreign-market devices do not qualify.
-
4A split predicate — one device for intended use, another for technological characteristics — is…
Multiple predicates are allowed with a primary predicate identified, but each comparison must stand whole. Splitting intended use and technology across two devices is inconsistent with the statute.
-
5The Special 510(k) exists for…
Special is for changes to your own legally marketed device where summary design control outputs can carry the equivalence argument — and FDA's goal is 30 days instead of 90.
-
6Your Special 510(k) modification also changes the intended use. What happens?
Eligibility is the gate. A Special that changes intended use converts to Traditional, and every plan built on the 30-day goal converts with it.
-
7The eSTAR template is mandatory for…
Every 510(k) goes in through the eSTAR template via the CDRH Customer Collaboration Portal. Its built-in completeness checks replaced the Refuse-to-Accept checklist — though a technical screening still guards the door.
-
8Which of these becomes a public document on clearance?
The 510(k) summary and the Indications for Use post publicly on clearance, permanently — competitors mine them for predicate research, so write them from the start as the version of your argument the world gets to keep.
-
9By day 60 of the review — Substantive Interaction — MDUFA commits FDA to tell you…
Day 60 is the first real signal of how the file is landing: either the review is proceeding interactively — questions by email while the clock runs — or an AI request is coming, which stops it.
-
10An Additional Information request does what to the review clock?
The clock stops and resumes only on a complete response — partial answers restart nothing, and a file left unanswered for 180 days is withdrawn. Answer every deficiency, in the order asked, and send it once.
A clean sweep — the decision letter is yours. You followed one premarket notification from doctrine to clearance without dropping a thread.
Strong — you hold the pathway. Skim the explanations you missed; each one points back to its lesson.
A solid pass through a dense pathway. The lessons are short — revisit the parts that pushed back.
The 510(k) rewards a second pass. Start again at part one — the course is built to be reread.
