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FDA device pathways, in plain terms

Short explainers for founders and the consultants who guide them. Each one cites the FDA guidance it summarises, and says plainly whether a regulatory professional has reviewed it yet.

• Choosing an FDA pathway
  510(k), De Novo, PMA or exempt: how class, predicates and risk decide the route. (draft)
• Traditional, Special or Abbreviated 510(k)
  Three ways to file a 510(k), and what decides between them. (draft)
• De Novo in plain terms
  For a new type of low-to-moderate-risk device with no valid predicate. (draft)
• 513(g) requests in plain terms
  Asking FDA how it classifies your product, and when a Pre-Sub is the better tool. (draft)
• Pre-Subs (Q-Submissions) in plain terms
  Getting FDA's written feedback on your plans before you file. (draft)
• The Breakthrough Devices Program
  What designation needs, what it brings, and what it doesn't change. (draft)

Free tools

• Classification lookup: FDA's class, regulation and panel for a device type.
• Predicate search: cleared devices under a product code.
• Checks: Special 510(k) · De Novo · 513(g) · Breakthrough.
• Quality-system template outlines: the 22 starting points in the app, section by section.