Regulatory Classification

Before you can build a regulatory dossier, you need to know exactly what class your product falls into and which pathway applies. Abkus Academic's classification wizard asks the right questions about your device or drug — sterility, invasiveness, intended use, contact duration — and returns a complete regulatory profile for each target market. No more guessing whether you need a 510(k) or a PMA.

How it works

1. Product Description You describe your product: name, intended use, mechanism of action, patient contact, sterility, implantability, and whether it contains an active drug component.
2. AI Classification The AI applies the decision trees from FDA 21 CFR, EU MDR Annex VIII, and ANVISA RDC 751/2022 to return the risk class for each jurisdiction.
3. Pathway Selection For each market, the system identifies the correct pathway: 510(k), PMA, De Novo, Q-Sub, IDE (US); MDR/IVDR CE Mark (EU); ANVISA regularization class (BR); CTA/MDA (CA).
4. Standards Matrix Returns the applicable ISO, IEC, and ASTM standards, the predicate device candidates (FDA), the Notified Body selection guide (EMA), and the compliance checklist for each standard.

What you get

• FDA: Class I / II / III, 510(k) vs PMA vs De Novo decision
• FDA predicate device search and substantial equivalence analysis
• EMA: MDR Class I / IIa / IIb / III, IVDR Class A–D
• ANVISA: RDC 751/2022 — Classes I, II, III, IV
• Health Canada: Medical Device Classes I–IV
• ISO 14971 risk management framework auto-generated
• 21 CFR Part 820 QMS requirements list
• Applicable standards matrix: ISO 10993, ISO 13485, IEC 60601, ISO 14971
• Q-Sub / Pre-Sub meeting checklist for FDA

Who it is for

• Startups with a product prototype needing regulatory strategy
• Regulatory affairs professionals entering a new market
• Biomedical engineering researchers planning clinical translation
• CROs advising clients on multi-market submissions
• University tech transfer offices assessing commercialization pathway