• Written PMTA documentation. Ask for the submission number or a copy of the marketing authorization letter. If they hesitate, walk away.
• Manufacturer contact. You should be able to reach someone who can answer compliance questions directly—not just a sales rep.
• Current status. Is the product authorized, pending, or denied? Pending is acceptable if the FDA hasn't acted, but denied is a hard stop.
• Batch traceability. Can they link a specific batch to a PMTA? If not, you're flying blind.