Most Class II medical devices reach the US market through one door: premarket notification under section 510(k). It is also the pathway people are most often handed without training — a submission format learned on the job, from templates, under deadline. Regulatory Academy's free 510(k) course was built to fix that: five lessons that walk the pathway end to end, sourced to FDA's own guidance documents rather than to folklore.
What the five lessons cover
The course follows the order the work actually happens in. It opens with what substantial equivalence legally means and what a clearance does and does not claim, then moves through choosing and defending a predicate device, selecting between the Traditional, Special, and Abbreviated tracks, assembling the file in eSTAR against the screening checklist, and finally the review itself — from submission through the SE letter, including where the clock stops.
- What a 510(k) actually is — substantial equivalence and what clearance means
- Choosing the predicate — and defending the choice when FDA pushes back
- Traditional, Special, or Abbreviated — picking the right track
- Building the file — eSTAR, RTA screening, and the testing burden
- Submission to clearance — the review, deficiency letters, and the SE decision
Built from the primary record
The course's method is the same one this publication uses: read the source document, not the summary of it. Lessons quote and link FDA's premarket notification guidance and the current Refuse to Accept policy, so what you learn is checkable against the record it came from — and stays current the way a slide deck never does. When user-fee negotiations move review timelines, as covered in our reporting on the MDUFA VI draft recommendations, the primary-record habit is what keeps a submission team from working to last year's rules.
Who it is for
The course was written for the people 510(k)s actually land on: engineers handed their first submission, quality professionals moving into regulatory, and consultants who want a defensible refresher. If that is you — or your team — the whole course is free at regulatoryacademy.com.
