EMERGENCY INTAKE

Full Name and Corporate Title *

Company Name

Direct Corporate Email *

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Current Submission Stage *

• 🚨 CRITICAL HOLD: We received an official FDA Hold / Additional Information (AI) Request Letter.
• We are actively drafting our pre-submission manuals (IFU, IOM, URRA).
• We have submitted an eSTAR 510(k)/De Novo and are awaiting a response.

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If facing an active FDA hold, how much time remains on your 180-day runway?

• Less than 60 days remaining (High Priority Emergency Rescue)
• 60 to 120 days remaining
• More than 120 days remaining
• N/A (Pre-submission alignment phase)

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What core technical areas did the FDA reviewer question or flag as deficient?

• Inconsistencies between our ISO 14971 Risk Files and user labeling.
• Vague cleaning, disinfection, or autoclave reprocessing parameters (ISO 17664-1).
• Use-related risks, interface errors, or human factors guardrails (IEC 62366-1).
• Post-market modification protocols, statistical floors, or hardware PCCPs.
• General technical synthesis or eSTAR formatting alignment.

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To help us map your technical defense, please paste the specific text or deficiency codes from your reviewer letter below (Optional):

Paste reviewer deficiency text here...

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