What problem does it solve? Regulatory teams preparing FDA Breakthrough Device Designation (BDD) requests often cannot tell whether their submission will survive a real CDRH review, leading to rejections or Additional Information (AI) requests that delay designation. ## Core Features & Use Cases - Simulated FDA CDRH Review: Evaluates BDD submissions against the official breakthrough criteria, including disease seriousness, unmet need, evidence package, benefit-risk, and indication scope. - Structured Deficiency Output: Produces each finding as Issue, FDA Concern, an English AI Request written in authentic FDA deficiency style, and a Chinese remediation guide. - Risk Summary: Concludes with an overall FDA review risk assessment and a prioritized list of fixes. - Use Case: A regulatory affairs specialist drafts a BDD request for a novel cardiac device and submits it for review; the skill identifies that the 'no approved alternatives' claim ignores a cleared competitor and drafts the exact AI question FDA would issue. ## Quick Start Review this BDD request and identify all deficiencies FDA would raise before granting Breakthrough Device Designation.
