Regulatory Classification

Know your regulatory pathway before you write a single dossier section.

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

Product Description

You describe your product: name, intended use, mechanism of action, patient contact, sterility, implantability, and whether it contains an active drug component.

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.

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).

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's included

✓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

Coverage

🇺🇸

United States — FDA

510(k) Premarket Notification
PMA (Premarket Approval)
De Novo classification request
IDE (Investigational Device Exemption)
Q-Submission (Pre-Sub) guidance
ISO 14971 + 21 CFR 820 + 21 CFR 882

🇪🇺

Europe — EMA / CE Mark

MDR 2017/745 — Classes I, IIa, IIb, III
IVDR 2017/746 — Classes A, B, C, D
Annex VIII classification rules (22 rules)
Notified Body selection guide
EUDAMED UDI registration
ISO 13485 QMS requirements

🇧🇷

Brazil — ANVISA

RDC 751/2022 classification rules
Classe I, II, III, IV risk levels
7-phase regularization roadmap
INMETRO technical standards alignment
GMP requirements per class

🇨🇦

Canada — Health Canada

Medical Device Classes I–IV
Medical Device Authorization (MDA)
Clinical Trial Application (CTA)
SOR/98-282 Medical Devices Regulations

Who is it 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

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