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Urgent risk/US
I sold my device in the US without clearance. Now what?
A crisis-search guide for founders who may have sold or marketed a medical device in the United States before resolving FDA status.
Direct answer
Stop guessing and preserve facts. If a product may have been marketed or sold before the FDA status was clear, the first useful step is to collect what was sold, when, to whom, under what claims, and what customers were told.
This is not a situation for a generic web answer. Use the guide to organize facts, then involve qualified regulatory and legal reviewers. The goal is to make the first review conversation faster and less chaotic.
Use this if
Reader
A founder or operator worried about a past United States sale or marketing claim
Trigger
A customer, investor, distributor, reviewer, or consultant raises a clearance concern
Blocked decision
What to document before calling regulatory counsel or a qualified consultant
Useful output
A calm evidence-preservation checklist, not a legal conclusion
Do these first
- Save website, brochure, invoice, distributor, training, and email evidence.
- List dates, units, customers, geographies, and claims.
- Separate actual sales from samples, demos, and noncommercial evaluations.
- Do not rewrite public claims until the evidence record is preserved.
What to collect before you ask for help
- All public and private claims used during the period.
- Product identifiers, versions, and shipment records.
- Customer complaint, adverse-event, and support history.
- Names of reviewers, consultants, or counsel already involved.
Common mistakes
- Deleting public pages before preserving what was said.
- Calling the product not a device without intended-use analysis.
- Trying to solve legal and regulatory facts in one unstructured meeting.
Public sources to start with