FDA Regulatory Support.
U.S. medical-device pathways, submission planning, and FDA interactions.
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.
Pathway planning
Review the regulatory question, the development stage, and the documentation needed to evaluate an appropriate U.S. pathway.
510(k) preparation
Prepare and review documentation for FDA clearance through the 510(k) pathway, including substantial-equivalence evidence and 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 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 togetherWhat 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.
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