FDA 510(k) Premarket Notification

Drafts a complete 510(k) submission package demonstrating substantial equivalence to a predicate device under 21 CFR Part 807, Subpart E.

Prerequisites

Gather before drafting:

1. 510(k) type — Traditional, Special, or Abbreviated
2. Predicate device — trade name, manufacturer, K-number, clearance date
3. Device classification — product code, regulation number, panel, class
4. Establishment registration — FDA registration number; U.S. agent if foreign
5. Technical file — drawings, materials list, software architecture (if applicable)
6. Performance data — bench testing, biocompatibility (ISO 10993), clinical/literature evidence
7. Proposed labeling — IFU, package insert, patient materials, packaging artwork

Submission Sections

1. Cover Letter