Medical Device Product Evidence Map for U.S. FDA and Health Canada market-entry research
Start with the device. Then map the public evidence around it. TrueMedDevice organizes public-source market-entry evidence around your product family, including similar-device records, safety history, classification clues, licence clues, guidance clues, and candidate review points for qualified RA/QA or consultant review.
This map shows what a Product Family Evidence Pack may organize around your product. It helps explain the research areas before or after you start product-family scoping.
For founders, manufacturers, RA/QA teams, and regulatory consultants. Source-backed evidence preparation — not regulatory, legal, or compliance advice.
U.S. / FDA view
Map public FDA evidence around your medical device product family.
Start with the device. Then map the candidate product-code, similar-device landscape, safety-history, recognized-standards, and consultant-prep evidence around it.
This is not regulatory, legal, or compliance advice. TrueMedDevice does not determine FDA classification, submission pathway, predicate status, substantial equivalence, compliance, safety, or effectiveness. We organize public-source evidence and prepare candidate review points so qualified RA/QA professionals or regulatory consultants can review and decide.
Center · Your product family
Your Product Family
Start with the device. Then map the public evidence around it.
Ring 0 — Product facts
Inputs about the device- Intended useOne-sentence statement of what the device is for.
- Indications / claimsPopulation, condition, or context the device is indicated for.
- Technology characteristicsPrinciple of operation, energy used, key materials, sensors, algorithms.
- Target usersClinician, technician, patient, lay caregiver — and where applicable, training requirements.
- Use environmentHospital, clinic, home, ambulance, mobile, sterile field, etc.
- Software / connectivityOn-device software, cloud connectivity, cybersecurity scope, interoperability.
- Accessories / componentsDisposables, sensors, leads, sterilization-sensitive parts, packaging.
- Target marketU.S. / FDA, Canada / Health Canada, or both. Phasing if both.
- Comparable productsWorking list of similar marketed devices already known to the team.
The center captures the device. The evidence areas below capture the public-source evidence TrueMedDevice can organize around it.
Ring 1 — Evidence areas
U.S. / FDA evidence areas
Click any evidence area to expand its meaning, why it may matter, which public sources are commonly reviewed, and what TrueMedDevice can prepare as candidate review points for qualified RA/QA review.
Review output — Next step
Hand the evidence to qualified RA/QA or consultant review
TrueMedDevice provides public-source research and evidence organization support. This page and any related Evidence Pack do not determine device classification, predicate suitability, regulatory pathway, licence route, clearance likelihood, compliance status, reportability, or legal/regulatory obligations. Final decisions remain with the company's qualified RA/QA, regulatory, legal, or consultant professionals.
Boundary: This is not regulatory, legal, or compliance advice. TrueMedDevice does not determine FDA classification, submission pathway, predicate status, substantial equivalence, compliance, safety, or effectiveness. We organize public-source evidence and prepare candidate review points so qualified RA/QA professionals or regulatory consultants can review and decide.
Related research and service pages
- U.S. Market-Entry Research Guide
- FDA 510(k) Similar-Device Research Workflow
- Health Canada Medical Device Licence Research Guide
- Medical Device Safety-History Scan Before Market Entry
- Prepare for a Regulatory Consultant Meeting
- U.S. / FDA Market-Entry Product Evidence Pack
- Canada / Health Canada Market-Entry Product Evidence Pack
- What is inside a Market-Entry Product Evidence Pack?
- Request a Product ID intake
Frequently asked questions
What is a Medical Device Product Evidence Map?
The Medical Device Product Evidence Map is a product-centered interface that organizes the public-source evidence areas commonly reviewed before a U.S. FDA or Health Canada market-entry conversation. The user's product family sits at the center; surrounding it are the evidence areas TrueMedDevice can research and organize — candidate product-code or device-class clues, similar-device or similar-licensed-device landscape, safety-history records, guidance and standards references, and consultant-prep questions. The map does not determine FDA classification, predicate suitability, regulatory pathway, licence route, clearance likelihood, compliance status, reportability, or legal obligations. Final decisions remain with qualified RA/QA, regulatory, legal, or consultant professionals.
How is this different from a regulatory checklist?
A regulatory checklist lists what to file. The Product Evidence Map lists what public-source evidence to gather and review before the consultant or RA/QA conversation. It is preparation, not a regulatory determination — every output is a candidate review point that a qualified professional must validate.
Can the Product Evidence Map determine my device class or predicate?
No. The Product Evidence Map surfaces candidate classification clues and a similar-device landscape, but it does not determine FDA classification, submission pathway, predicate status, substantial equivalence, Health Canada device class, MDL/MDEL eligibility, or licence outcome. Those are determinations the regulator makes when it accepts a submission, with input from the manufacturer's qualified RA/QA and consultant team.
What is the difference between the U.S. FDA view and the Health Canada view?
The U.S. FDA view maps the public FDA evidence layer (FDA Product Classification, 510(k) records, similar-device landscape, indications and technology comparisons, FDA guidance / special controls, recognized standards, FDA Recalls, MAUDE, Warning Letters, Safety Communications). The Health Canada view maps the public Health Canada evidence layer (Schedule 1 SOR/98-282 class clues, Medical Device Licence records, similar-licensed-device landscape from MDALL, MDALL / licence-holder landscape, Recalls and Safety Alerts, Public Advisories, Foreign Risk Notifications, application-checklist guidance, labelling comparison). Both views share the consultant-prep evidence area and a deliverable Product Evidence Pack.
What evidence does TrueMedDevice actually deliver?
TrueMedDevice delivers source-backed evidence in two service deliverables: the U.S. / FDA Market-Entry Product Evidence Pack (from US$1,800) and the Canada / Health Canada Market-Entry Product Evidence Pack (from US$1,500). Each pack is a source-cited artifact — every claim links back to a public FDA, Health Canada, or MDALL record with access date — for qualified RA/QA or consultant review.
Does the Evidence Map collect confidential product data?
No. This page is a research orientation interface. It does not collect confidential product data, regulatory submissions, or commercial information. If you want TrueMedDevice to run the public-source research against your specific product family, request a Product ID intake on the linked intake page.
TrueMedDevice provides public-source research and evidence organization support. This page and any related Evidence Pack do not determine device classification, predicate suitability, regulatory pathway, licence route, clearance likelihood, compliance status, reportability, or legal/regulatory obligations. Final decisions remain with the company's qualified RA/QA, regulatory, legal, or consultant professionals.
This is not regulatory, legal, or compliance advice. TrueMedDevice does not determine FDA classification, submission pathway, predicate status, substantial equivalence, device class, MDL/MDEL eligibility, licence outcome, compliance, safety, or effectiveness. We prepare source-backed evidence and candidate review points so qualified RA/QA professionals or regulatory consultants can review and decide.