FDA 510(k) Submission Workshop
A hands-on workshop on building a 510(k): pathway choice, predicate strategy, evidence plan, eSTAR, Pre-Sub questions and responding to FDA requests.
A 510(k) is a structured argument that your device is substantially equivalent to a legally marketed predicate. Weak predicate logic, thin test rationale or an incomplete eSTAR package are the usual reasons submissions are delayed. This workshop walks you through building a 510(k) from the first decision to the final package, with a focus on the choices that determine whether FDA’s review goes smoothly.
Who this workshop is for
- Regulatory affairs professionals preparing their first or next 510(k).
- Engineers and quality staff who write the testing and documentation that goes into a submission.
- Startups deciding between a 510(k) and a De Novo request.
- Professionals building skills for US regulatory roles.
Workshop outline
| Session | Focus | Hands-on output |
|---|---|---|
| 1. Pathway and classification | Product codes, exemptions, 510(k) versus De Novo or PMA | Pathway decision memo |
| 2. Predicate strategy | Choosing and comparing predicates, intended use and technological differences | Substantial equivalence comparison table |
| 3. Evidence plan | Performance testing, standards, biocompatibility, sterilization, software, electrical safety, human factors | Test plan with rationale for each test |
| 4. Using eSTAR | Structure of the electronic template, required sections, common completeness gaps | Section-by-section readiness checklist |
| 5. Pre-Sub and FDA interaction | When to ask FDA, how to frame questions, handling feedback | Draft Pre-Sub question set |
| 6. Review and response | Acceptance review, additional information requests, responding well | Response plan for typical deficiencies |
How the workshop works
Participants work on a sample device or, for company groups, on their own product, with exercises in each session. Format, duration and group size are agreed on enquiry.
What you take away
- A reusable 510(k) planning checklist.
- A predicate comparison and substantial equivalence template.
- A test rationale outline to adapt for your device.
- A clearer understanding of how FDA reviewers read a submission.
The workshop teaches the method. It does not guarantee clearance, and decisions on your own submission remain with FDA.
Read before you enrol
Useful background: the 510(k) submission process, selecting the predicate, Pre-Submission meetings and 510(k) deficiency letters.
Frequently asked questions
Do I need my own device to take part?
No. Individual participants use a sample device. Company teams can work on their own product if they prefer.
Does the workshop cover De Novo and PMA?
The focus is the 510(k). De Novo and PMA are covered at the level needed to choose the right pathway.
Is it relevant for the RAC (Devices) exam?
Yes, the US pathway knowledge overlaps with exam content, although the workshop is not exam preparation. For that, see our RAC study material.
How do I get dates, format and fees?
Use the enquiry form below and the team will reply with the current options.
Enquire about this workshop
Tell us your role, your device type and your experience with FDA submissions.
Enquire about the 510(k) workshop
Ready to take the next step?
Questions? Email aptskill6@gmail.com and the AptSkill team will respond promptly.