Regulatory Pathway Orientation Worksheet
Answer six questions about the product and get back the questions a regulator asks in response, what each one establishes, and what evidence answers it. Deliberately returns questions rather than a classification: pathway determination turns on intended use, mode of action and jurisdiction together, and belongs to a qualified adviser.
OUTPUT
TIME
Limitations — read before you rely on this
- This worksheet makes no determination. It does not classify a product, decide a regulatory pathway, or state a submission type — a founder acting on such a verdict from a web form is the specific failure it is shaped to avoid.
- SPEQ is not a validated system, is not a regulatory consultancy, and has no affiliation with any regulatory authority. Reproduce this assessment with a qualified adviser working against your specific framework.
- The question set is general. A particular product, claim, combination or jurisdiction can raise questions this worksheet does not contain.
- Nothing recorded here carries any weight with an authority and must never be cited as the basis for a regulatory position.
WHAT THIS CALCULATES
The set of questions a regulator asks about a product, ordered as they are normally settled, with what each question establishes and what evidence answers it. It computes a question set, never a classification, a pathway or a submission type.
THE METHOD
questions = intended_use + triggered(nature, claim, mode_of_action, decision_role, setting)- questions
- The ordered set returned. Every question carries what it establishes and what answers it, so the reader can tell a prepared answer from a fluent one.
- intended_use
- The opening question, present for every product: what it is intended to do, for whom, in what setting. Almost everything downstream follows from it.
- triggered
- The further questions each answered characteristic raises. Each returned question states which answer surfaced it, so no rule is hidden.
- nature
- What the product is physically — chemical, biological, device, software, or a combination.
- claim
- Whether the claim is to diagnose, treat, prevent or mitigate. What is claimed, not what the technology could do.
- mode_of_action
- Whether the primary effect is achieved chemically or metabolically, which is the usual determinant where more than one framework could apply.
- decision_role
- Whether the output informs a clinical decision, which scales the evidence expected of it.
- setting
- The intended user — trained clinician, laboratory staff, a lay user, or not yet settled.
This is a selection rule, not an arithmetic. Nothing is scored, weighted or summed, because a total would read as a determination.
THE INPUTS, AND WHAT THEY MEAN
- What is the product, physically?
- The material nature of the thing — a small molecule, a biological, a physical device, software, or a combination of these. It does not determine the framework by itself, but it decides which questions are asked next.
- Does the claim diagnose, treat, prevent or mitigate?
- The threshold question for most regulatory frameworks. It turns on what is claimed in writing and in promotion, not on what the technology is capable of doing.
- Is the primary effect chemical or metabolic?
- How the product achieves its principal effect on the body. Where a product could sit under more than one framework, the primary mode of action is usually what settles it.
- Does the output inform a clinical decision?
- Whether anyone acts clinically on what the product reports. This is what proportionate evidence is scaled against, and it is a property of the workflow rather than of the technology.
- Who is the intended user?
- A trained clinician, laboratory staff, or a member of the public. Lay use raises human-factors questions that instructions being available does not answer.
- Is the claim written down anywhere?
- A website, an investor deck or a grant application all count. Promotional material is read as evidence of intended use regardless of what the formal claim says.
What will a regulator ask you first?
Answer six questions about the product. SPEQ returns the questions a regulator asks in response, in the order they are normally settled, and what each one establishes. It does not classify the product or name a pathway — that determination belongs to a qualified adviser working against a specific framework, and a founder acting on a web form’s verdict is exactly the failure this tool is shaped to avoid.
1. What is the product intended to do, for whom, in what setting?
Intended use, which determines almost everything downstream — the regulator, the evidence and the postmarket obligations all follow from it rather than from the technology.
Answered by: A written, dated intended-use statement, controlled from the moment it exists.
2. What stops a user reading this as a medical claim?
Whether the absence of a medical claim survives contact with how the product is described and used, which is where a "wellness" or "research use only" position most often fails.
Answered by: Marketing material, the user interface, and how users actually describe the product back to you.
3. Who is the intended user — and what would change if it were the other one?
That the user is a decision rather than an outcome. The same claim for a specialist and for general practice are different products with different evidence.
Answered by: A stated intended user, with the excluded populations recorded as exclusions.
- Every version of the intended-use statement, and what changed between them
- Marketing and pitch material as issued, which is evidence of intended use regardless of the formal claim
- The reasoning for any population or setting you are deliberately excluding
HOW TO READ THE OUTPUT
- The output is the questions, not the answers. A worksheet cannot classify a product: classification turns on intended use, mode of action and jurisdiction together, and it is made by the sponsor against a specific framework.
- Take the questions to a pre-submission or scientific-advice meeting as positions with evidence behind them. A programme that arrives with reasoned positions and named uncertainties is read very differently from one that arrives with a conclusion.
- Where a question has no answer yet, that is the finding. An unanswerable question is cheaper to discover now than after the evidence has been gathered against a claim that later moves.
- The three records under "start preserving now" apply whatever the questions resolve to, which is why they are separated from them.
WORKED EXAMPLE
A university spin-out has an algorithm that flags likely sepsis from routine vitals, intended for use by ward clinicians, with a claim written into its grant application.
- Product nature
- Software, an algorithm or a model
- Medical claim
- Yes
- Primary effect chemical or metabolic
- No
- Output informs a clinical decision
- Yes
- Intended user
- A trained clinician
- Claim written down
- Yes
RESULT
The worksheet does not say whether this is a regulated device. It says the team must be able to answer, in writing, what the algorithm is for and what happens clinically when it is wrong — and that the grant application is already a written description of intended use that every other document now has to match.
REGULATORY BASIS
- IMDRF N10
- Supplies the shared vocabulary for describing software intended for a medical purpose, which is what makes the software question answerable in terms a regulator recognises.
- IMDRF N12
- Frames software risk categorisation around the significance of the information to the clinical decision and the state of the healthcare situation, which is why the workflow question is asked rather than a technology question.
- ICH Q9(R1)
- Establishes that risk is assessed against harm to the patient, which is the framing behind asking what happens when an output is wrong rather than how accurate the model is.