fda-consultant-specialist

Choose 510(k) when a legally marketed predicate device exists and your device is substantially equivalent. Use De Novo for novel low-to-moderate risk devices without a predicate, and PMA for high-risk Class III devices. The skill provides a decision framework with timelines and costs for each pathway.

A 510(k) requires Form 3514, device description, Indications for Use (Form 3881), substantial equivalence comparison, performance testing data, labeling, and a 510(k) summary per 21 CFR 807.87. The included tracker script checks your project folder for these required documents and reports readiness percentage.

HIPAA applies when your device creates, stores, transmits, or accesses Protected Health Information, such as connected devices transmitting patient data or SaMD storing patient records. Standalone diagnostics without data transmission are generally exempt. The skill includes a full Security Rule safeguards framework.

FDA requires a threat model, security risk assessment, security architecture description, SBOM in CycloneDX or SPDX format, security testing results, and a vulnerability management plan. Tier 1 devices with network connectivity and potential patient harm need comprehensive penetration testing documentation.

Run the fda_submission_tracker.py script against your project directory with a submission type flag. It calculates elapsed review days, projected decision dates based on FDA goals (90 days for 510(k), 150 for De Novo, 180 for PMA), and flags AI hold periods.

Common RTA issues include missing user fee payment, incomplete Form 3514, no identified predicate device, and inadequate substantial equivalence comparisons. The skill's reference guide lists prevention steps for each deficiency to avoid acceptance review rejection.