Picking the wrong regulatory pathway costs 12\u201318 months \u2014 get it right before you write a single page of your submission.
Instant download. For regulatory affairs leads, product engineers, and RA consultants.
This toolkit gives you the decision frameworks, worksheets, and documentation templates to determine your regulatory pathway correctly \u2014 before you invest in the wrong submission.
First-time regulatory strategy for a new device — need to pick the right pathway before committing budget and timeline.
Making regulatory strategy decisions early in the design process when pathway choice shapes the entire development plan.
Scoping client submissions and need a structured, defensible framework for pathway recommendation — not just experience-based opinion.
Evaluating regulatory risk in due diligence — is the company on the right pathway? Is their predicate defensible? What is realistic timeline?
From initial classification through pathway justification and Pre-Sub documentation.
Comprehensive decision framework for choosing between 510(k), De Novo, PMA, and Exempt pathways. Covers FDA classification panels, risk levels, predicate availability, and time-to-market implications. Includes flowcharts for each decision point with citations to 21 CFR and FDA guidance documents.
Structured predicate comparison template covering intended use, indications for use, technological characteristics, and performance data requirements. Walks through the SE decision tree FDA uses internally — same intended use, same technological characteristics, different technological characteristics with equivalent safety/effectiveness.
Systematic framework for identifying, evaluating, and documenting predicate devices. Includes 510(k) database search strategies, multi-predicate comparison tables, split-predicate justification templates, and documentation for Pre-Sub meetings. Covers both primary and secondary predicate selection.
Step-by-step decision framework for when 510(k) is not appropriate and your device is novel but low-to-moderate risk. Covers De Novo eligibility criteria, classification rationale, risk-based classification determination, and how De Novo differs from PMA. Includes the full De Novo request content outline per FDA guidance.
Complete checklist covering 21 CFR Parts 862-892 to determine if your device qualifies for 510(k) exemption. Covers Class I and Class II exempt device types, limitations of exemptions, and documentation requirements. Identifies when exemption does NOT apply despite device classification.
Formal memo template for documenting and defending your pathway selection to FDA, investors, and internal stakeholders. Structured for IDE, IND, and Pre-Sub documentation. Covers regulatory rationale, predicate analysis summary, risk classification justification, and timeline/cost projections by pathway.
The #1 regulatory strategy mistake: choosing 510(k) when your device has no substantially equivalent predicate. The pathway selection guide forces a structured analysis before you commit to a submission type — saving 12-18 months if you would have picked wrong.
A weak predicate means additional testing, longer review times, and higher risk of Additional Information requests. The predicate matrix gives you a systematic search and comparison method to identify the predicate that clears fastest.
FDA reviewers, investors, and acquirers all want to see why you chose your pathway. The justification memo template creates a formal record of your regulatory rationale — critical for Pre-Sub meetings, board presentations, and due diligence.
“We spent two months preparing a 510(k) before realizing our device had no valid predicate. These templates would have caught that in week one. The pathway selection guide and predicate matrix are exactly what we now use at AB Medical before writing a single page of any submission.”
Joshua Millage, CEO — AB Medical Technologies
“Pathway determination is where the most expensive mistakes happen in regulatory strategy. We have seen startups burn six figures on a 510(k) that should have been a De Novo from day one. This toolkit forces the right analysis upfront — predicate search, SE worksheet, pathway justification — before you commit resources.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
510(k) requires demonstrating substantial equivalence to a legally marketed predicate device — same intended use, same or different technological characteristics with equivalent safety and effectiveness. De Novo is for novel, low-to-moderate risk devices where no predicate exists. De Novo creates a NEW classification and can itself become a predicate for future 510(k)s. The toolkit includes decision trees for both pathways and the criteria that determine which is appropriate for your device.
Substantial equivalence requires: (1) same intended use as the predicate, AND (2) either the same technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. The Substantial Equivalence Worksheet walks through each element with specific questions FDA reviewers evaluate — including how to handle split predicates and how to document technological differences.
Start with the FDA 510(k) database, filtering by product code and review panel. The Predicate Identification & Comparison Matrix provides a structured search strategy covering the 510(k) database, classification database, product code lookup, and guidance documents. It also covers when and how to use multiple predicates (split predicate approach) and how to evaluate predicate strength.
No. This is a practitioner reference toolkit based on FDA regulations, guidance documents, and real submission experience. Consult your regulatory counsel for formal compliance opinions specific to your device.
FDA guidance, warning letters, and compliance intel \u2014 delivered daily by RegWatch Daily.
Six documents. Instant download. 510(k), De Novo, PMA, and Exempt \u2014 know which one before you start.
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