CLEARED!
a game · take your device to market
510(k)Easy
De NovoMedium
PMAHard
Effort3
Boxes0/5
Review clock:
Welcome. Choose a pathway, then build your submission before the review clock runs out.
The FDA review
The Reviewer
Bureaucracy: thorough
Substantive review
Your submission: fill and lock every box, then submit
You: the Manufacturer

How to play PINNED

Goal: fill every box of your submission, then submit before the review clock reaches 0. The FDA pushes back each turn: hold the right response.

Each of your turns

  1. Gain 3 Effort (no carryover).
  2. Drag a card onto a box, or click to auto-file it.
  3. A full box locks and the FDA can no longer touch it.
  4. You may swap your hand to redraw, but only before you file a document, and it ends your turn.
  5. End turn: draw to 5, clock drops 1, the FDA acts.

Responses must match

  1. Each FDA action is cancelled by its matching response.
  2. No match in hand? You take the hit instead.
  3. A Great Idea cancels anything, once per game.

Card types

Document: fills a box
Action: tempo and engine
Response: free, matches an FDA action
Wildcard: Qity QMS, Qity Service and Qity Support
FDA: a review action
Facing a real submission, not a card game? Qity turns the work your team already does into compliance evidence. qity.be · info@qity.be