FDA Submission Track Record Checklist

Free Guide · Blue Goat Cyber · Updated 2026

CHECKLIST · 1 PAGE · PROSPECT RESOURCE

Submission Track Record by Device Class & Pathway Evaluate cybersecurity partners on FDA outcomes, not generic logos.

Logos prove brand reach. Submission outcomes prove fit. Use this to compare partners on the dimension FDA reviewers actually care about.

Volume & breadth Total FDA submissions the partner has authored cybersecurity sections for?

Number of distinct device classes (Class II, Class III) covered?

Submission types covered (510(k), De Novo, PMA)?

Years of continuous MedTech-only practice?

Outcome quality

Rate of Refusal-to-Accept on cybersecurity sections they authored?

Number of FDA Additional Information requests handled in the last 24 months?

Average time from submission to clearance for similar devices?

Postmarket cybersecurity issues attributable to their submission work?

Reference availability

Will they share redacted submission artifacts on request?

Are reference customers available in your device class?

Is the senior practitioner who will lead your work named in the proposal?

How to read it. A partner who can answer the first two sections with specifics is a MedTech cybersecurity firm. A partner who can only answer the first section is an IT firm with MedTech logos.

NEXT STEP → Book a 20-minute reference call to walk through redacted artifacts from devices similar to yours. Book your discovery call: go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session

Page 1 · © Blue Goat Cyber · 250+ FDA submissions, zero rejections, since 2014

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