How should I prepare for my first regulatory consultant meeting about a medical device?

Each block has a short rationale and the artifacts you should arrive with. The blocks work for U.S./FDA-only, Canada/Health Canada-only, or both-jurisdictions scopes.

1. 1

   Product identity and intended use

   The single most useful artifact to bring is a short written product description plus an unambiguous intended-use (FDA) or intended-purpose (Health Canada) statement. The consultant reads this first, every time. Get it onto one page before the call.

   Bring to the meeting

   • ✓Written product description (device type, principle of operation, energy used, materials, components, accessories, software)
   • ✓Written intended-use / intended-purpose statement (intended population, intended user, intended environment, intended clinical purpose)
   • ✓Any IFU drafts, marketing claims, or label copy you have started
2. 2

   Jurisdiction target — U.S., Canada, or both

   Naming the target market(s) up front avoids 20 minutes of context. If the answer is "both," say so — and be explicit if one market is primary and the other is later phase. Each jurisdiction has its own terminology, its own forms, and its own public sources, and the consultant will scope accordingly.

   Bring to the meeting

   • ✓Named primary market (U.S. / FDA, Canada / Health Canada, or both)
   • ✓Phasing — if both, which one first and on what timeline
   • ✓Any prior interaction with FDA (Pre-Submission / Q-Sub) or Health Canada (correspondence or pre-application meetings)
3. 3

   Similar-device / candidate predicate clues

   For U.S./FDA, the question is which candidate predicate devices exist for a 510(k) similar-product comparison. For Canada / Health Canada, the question is which similar devices are already licensed and visible in MDALL. A short, source-cited candidate shortlist saves the consultant from having to do the search live.

   Bring to the meeting

   • ✓Candidate predicate shortlist with K-numbers, applicants, decision dates (U.S.)
   • ✓Candidate similar-licensed-device shortlist with licence numbers, applicants, classes (Canada)
   • ✓A simple similar-product comparison table — direct vs indirect, with intended use and key technological characteristics noted
4. 4

   Classification / product-code / licence-class candidate clues

   For FDA, the question is which candidate three-letter product code(s) and which candidate device class apply. For Health Canada, the question is which Class I / II / III / IV under SOR/98-282 Schedule 1, plus MDL or MDEL applicability. These are candidate clues — never determinations.

   Bring to the meeting

   • ✓Candidate FDA product code(s) with the CFR citation each maps to
   • ✓Candidate FDA device class (I, II, III)
   • ✓Candidate Health Canada device class (I, II, III, IV) under SOR/98-282
   • ✓Candidate MDL vs MDEL applicability notes tied to the firm's role
5. 5

   Public safety history for the product family

   Recalls, adverse events, warning letters, public advisories, and incident reports for similar devices shape the risk-management conversation. The consultant uses these as candidate review points for ISO 14971 risk file scoping and verification planning.

   Bring to the meeting

   • ✓Scoped, dated safety-history scan covering candidate similar-device set
   • ✓Failure-mode summary across the product family
   • ✓Recurring labelling, usability, or cybersecurity concerns in the category
6. 6

   Recalls, adverse events, and safety alerts — specifics

   Beyond the categorical scan, the consultant will ask about specific public records relevant to the candidate predicate or candidate similar-licensed device. Pull these into a short table with citation and date.

   Bring to the meeting

   • ✓FDA Recalls relevant to candidate predicates (with FDA classification: Class I, II, III)
   • ✓FDA Warning Letters relevant to the candidate-predicate manufacturers, scoped + dated
   • ✓MAUDE narrative summary by failure-mode category — never raw counts as if they were rates
   • ✓Health Canada Recalls, Public Advisories, Foreign Risk Notifications relevant to similar-licensed devices
7. 7

   Standards, guidance, and forms to discuss

   Candidate recognized standards, candidate guidance documents, and the relevant forms / fees / submission templates frame the testing-strategy and submission-planning conversation. Surfacing these in advance means the consultant can spend time on judgment, not retrieval.

   Bring to the meeting

   • ✓Candidate recognized consensus standards (ISO 13485, ISO 14971, ISO 10993, IEC 62366, IEC 60601, applicable special-controls standards)
   • ✓Candidate FDA guidance documents and special-controls guidances for the product code
   • ✓Candidate Health Canada guidance documents for the device category
   • ✓Current FDA MDUFA user-fee figures and eSTAR references; current Health Canada licence fee figures; MDSAP / ISO 13485 documentation expectations
8. 8

   Open questions for the consultant

   Finally — and most underestimated — the prep block that has the highest leverage. Write the questions you actually want answered. The consultant's value is in judgment; structuring the call around your decision-relevant questions captures that judgment efficiently.

   Bring to the meeting

   • ✓Open questions about classification and pathway / licence choice
   • ✓Open questions about predicate selection or similar-licensed-device strategy
   • ✓Open questions about testing strategy and standards conformance
   • ✓Open questions about Pre-Submission / Q-Sub (U.S.) or pre-application engagement (Canada)
   • ✓Open questions about timeline, fees, and sequencing of MDSAP / ISO 13485 work