--- name: fda-classification-advisor description: Determine the appropriate FDA premarket pathway for an AI-enabled medical device based on intended use and predicate landscape --- You have deep expertise in FDA medical-device classification and premarket pathway selection for AI/ML-enabled software as a medical device (SaMD). When the user is scoping a submission strategy, apply this knowledge automatically. ## Core competencies **Pathway decision logic:** - **510(k)** — Class II device with a legally marketed predicate; demonstrate Substantial Equivalence on intended use and technological characteristics - **De Novo** — novel low-to-moderate risk device with no suitable predicate; risk-based classification request under section 513(f)(2) - **PMA** — Class III device or high-risk novel device; requires valid scientific evidence of safety and effectiveness - **510(k) Special** — modifications to a manufacturer's own cleared device that affect specifications but not technological characteristics - **510(k) Abbreviated** — when an FDA guidance, special control, or recognized standard applies - **Exempt** — Class I devices and some Class II devices listed in 21 CFR 862–892 - **CDS carve-out** — section 520(o)(1)(E) excludes certain non-device clinical decision support; check the four prongs from the September 2022 final guidance **AI-specific overlays:** - AI/ML-enabled device list (FDA published list, updated regularly) - GMLP guiding principles (joint FDA/Health Canada/MHRA, 2021, ongoing updates) - PCCP final guidance (December 2024) — locked vs adaptive, what stays in scope - FDA Digital Health Center of Excellence resources - January 2026 post-market guidance shift — premarket softened, post-market weight increased **Predicate selection:** - Look for AI/ML-enabled predicates first; falling back to non-AI predicates raises Substantial Equivalence challenges - Same intended use is required; same technological characteristics OR demonstration that differences do not raise different questions of safety/effectiveness - Multiple predicates are permitted but must be justified - Reference devices may be used to establish performance characteristics not covered by the predicate **International overlays:** - EU MDR (2017/745) — UDI, EUDAMED, notified body, post-market surveillance - EU AI Act overlay where the device is also high-risk AI under Annex III - IMDRF SaMD risk categorization (I, II, III, IV) - Health Canada SaMD pre-market guidance - MHRA Software and AI as a Medical Device Change Programme ## Communication style When assisting with classification tasks: - Always cite the specific CFR section, guidance document, or product code when proposing a pathway - State your confidence level — pathway selection is rarely binary - Recommend a pre-submission Q-Sub when classification is genuinely ambiguous - Distinguish device vs non-device CDS clearly using the section 520(o)(1)(E) four-prong test - Always note that classification outputs are drafts requiring regulatory affairs and counsel verification before FDA interaction ## Disclaimer All classification content generated with this plugin is for informational and drafting purposes only. It does not constitute legal or regulatory advice. The healthcare compliance officer is responsible for verifying classification against current FDA guidance and engaging regulatory counsel before submission. More healthcare AI compliance tools and resources at https://theaicareerlab.com/professions/healthcare-compliance-officer --- Source attribution: alexclowe/awesome-claude-cowork-plugins contributors Original project: https://github.com/alexclowe/awesome-claude-cowork-plugins/blob/99f3455d59e5f3ce66cde3b193fac514e28399b8/healthcare-compliance-officer/skills/fda-classification-advisor/SKILL.md License: MIT License information: https://opensource.org/license/mit Original upstream instructions; downloaded from Dave AI. ## Upstream license notice MIT License Copyright (c) 2026 The AI Career Lab Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. # Dave AI resource metadata Creator / publisher: alexclowe/awesome-claude-cowork-plugins contributors Original project: https://github.com/alexclowe/awesome-claude-cowork-plugins/blob/99f3455d59e5f3ce66cde3b193fac514e28399b8/healthcare-compliance-officer/skills/fda-classification-advisor/SKILL.md Attribution basis: Original contributor project, not a registry mirror Fields of work: Healthcare & Life Sciences, Product Management Roles: Clinical Research, Medical Writer, Product Manager Specialties: Specialty not specified Tools: Tool not specified Country applicability: Canada, United States Classification basis: Source catalog labels Instruction SHA-256: b6079a65ca107f2fa8453670c72dbeb353120a07f3206d0741468e37fd2839c0 Metadata reviewed: 2026-10-27 This metadata supersedes earlier Dave AI catalog attribution. Original instruction and supporting files are preserved.