FDA Strategy.
U.S. medical-device pathways, submission planning, and FDA interactions.
Focus of this practice
A considered approach to the U.S. market.
A U.S. regulatory plan starts with the device, its intended use, and the evidence available. Crossroads helps bring these considerations together before a submission or product decision.
The scope of support is agreed around your product, priorities, and available information.
Potential areas of support
Pathway planning
Review the regulatory question, the development stage, and the documentation needed to evaluate an appropriate U.S. pathway.
510(k) preparation
Support the planning, preparation, and review of submission documentation, including identification of gaps that need to be addressed.
De Novo guidance
Consider the questions and documentation associated with a De Novo classification request. This is a separate pathway from a 510(k).
FDA correspondence
Organize submission-related questions and responses, and support the regulatory documentation behind agency interactions.
When to start
When a U.S. regulatory decision is ahead.
You may be preparing a first submission, evaluating a new device, or responding to an agency question. The initial discussion establishes the specific decision and the information available to support it.
How we work togetherA useful starting point
What to bring
to the first discussion.
- Device description and intended use
- Development stage and existing evidence
- Previous submissions or agency correspondence
A brief, non-confidential overview is enough to begin. Detailed documents can be discussed once the engagement arrangements are agreed.
Start a conversation
Discuss your regulatory or quality needs.
Tell us about your product, your priorities, and the question ahead. A brief, non-confidential overview is enough to begin.
Contact Crossroads