FDA Premarket Submissions
Each premarket pathway carries its own evidentiary standard and timeline. A well-used Pre-Submission meeting surfaces the questions a reviewer would otherwise raise months later as a deficiency, while the answer still costs a conversation rather than a repeated study.
- 510(k): Traditional, Abbreviated, and Special
Each 510(k) type carries different evidentiary expectations and timelines. We determine which applies to your device and build the submission to match what that pathway actually requires, not more, not less.
- PMA: Premarket Approval Application and supplements
PMA is the highest-evidence pathway FDA offers, and the modular and supplement processes each carry their own strategic considerations. We help structure the submission and manage supplement strategy as your device evolves post-approval.
- De Novo: Classification request preparation
For novel, low-to-moderate risk devices without a predicate, De Novo creates a new classification, and often a new predicate for future devices. We build the risk-based rationale FDA needs to grant it.
- Q-Sub / Pre-Sub: written feedback and meeting requests
A well-prepared Pre-Submission meeting can resolve the questions that would otherwise surface as deficiencies months later. We prepare the briefing document and meeting strategy to get direct, actionable FDA feedback before you finalize your evidence plan.
- IDE: Investigational Device Exemption
Significant risk devices need an approved IDE before clinical investigation can begin. We prepare the application and the supporting risk determination.
- Change assessment memos
Not every product change requires a new 510(k), but getting that judgment wrong in either direction creates real risk. We assess proposed modifications against FDA's own guidance to determine whether a new submission is required.