The route to market is a decision long before it is a submission.
Every product reaches its market through a defined route: a 510(k) or a De Novo, an IND that matures into an NDA or a BLA, a CE mark under MDR or IVDR, a Health Canada licence resting on an MDSAP audit. The frameworks themselves are public — every one of them is published, and none of them is secret. What is not published is which route your product actually qualifies for, what evidence that route will demand once a reviewer has it in hand, and how the choice you make in the United States constrains the file you submit in Europe two years later. That judgment is the work. It is also the difference between a route and a detour.
Nearly every expensive regulatory surprise traces back to one of these four being made casually, late, or by someone without the reps to make it. They are taken in order, and each one inherits the last.
What the product legally is — device, drug, biologic, IVD, or a combination — and the risk class that follows. Everything downstream inherits this answer, including who reviews it.
Which routes that classification opens: a predicate-based 510(k), a De Novo where no predicate exists, a PMA carrying its own clinical evidence, or an IND that matures into an NDA or BLA.
What the chosen route genuinely demands — bench, biocompatibility, usability, clinical investigation — and, just as decisive, what it does not. Scope is where budgets are won and lost.
The order you enter markets. US-first or EU-first changes the evidence you generate, what a Notified Body will accept, and how long the second filing takes to clear.
FDA regulates by product type and by risk. The route you qualify for sets the evidence you owe, the review clock you sit on, and which expedited programs are open to you. Choosing it correctly is a strategic act; discovering it late is an expensive one.
Premarket notification demonstrating that a device is substantially equivalent to a legally marketed predicate. The route most Class II devices take, and the one where a weak predicate argument costs the most time.
FDA pathway supportRisk-based classification for a novel device with no predicate to point to. You are not matching an existing device — you are writing the special controls the next one will be measured against.
FDA pathway supportPremarket approval: the most demanding device route, reserved for Class III devices that must carry their own valid scientific evidence of safety and effectiveness.
FDA pathway supportInvestigational Device Exemption — the authorization to put an unapproved device into a clinical study so it can generate the evidence a PMA or De Novo will require.
Clinical & nonclinicalInvestigational New Drug application: the filing that lets a drug or biologic enter human trials, and the file every later submission is built on top of.
Submission strategyNew Drug Application — the marketing application for a new small-molecule drug, including the 505(b)(2) route that leans on evidence you did not generate.
505(b)(2) pathwayBiologics License Application: the licensure route for biologics under the Public Health Service Act, including the 351(k) pathway for biosimilars.
Biosimilar strategyEmergency Use Authorization — a temporary authorization for unapproved products, or unapproved uses, while a declared emergency is in force. A market entry with an expiry date.
Expedited development and priority review for devices addressing serious or irreversibly debilitating conditions. Earned on the strength of the clinical case, not the application.
Accelerated pathwaysThe expedited program for devices treating or diagnosing conditions less serious than those Breakthrough covers — the same engagement model, a different eligibility bar.
Accelerated pathwaysThe formal channel for FDA feedback before you file — Pre-Submissions above all. The cheapest place to discover that your evidence plan does not survive contact with the review division.
FDA meeting strategyAnnual registration of the facilities that manufacture, repackage, or import FDA-regulated product. Unglamorous, and a standing inspection trigger when it is wrong.
GxP complianceThe listing of every device you have in commercial distribution. It must match what you actually ship — and what your 510(k) said you would ship.
Regulatory operationsUnique Device Identification on the label and a matching record in FDA's GUDID database. A data-integrity obligation that quietly mirrors your labeling and change control.
LabelingThe Quality Management System Regulation, which took effect on February 2, 2026 and rebuilt 21 CFR 820 around ISO 13485:2016. One system, read by two regulators.
QMS implementationEurope does not approve a device once and step back. It grants conformity against a regulation, then expects you to keep earning it — through clinical or performance evaluation, surveillance, vigilance, and the data you file into EUDAMED.
Regulation (EU) 2017/745. Higher classification, deeper clinical evidence, and a Notified Body relationship that does not end at certification.
EU MDR & IVDRRegulation (EU) 2017/746, as amended by (EU) 2024/1860. It moved most diagnostics into Notified Body scope for the first time and reset the transition dates around them.
IVD regulatoryThe mark that lets you place a device on the EU market — your declaration of conformity, in almost every case underwritten by a Notified Body's certificate.
European strategyThe planned, continuous appraisal of clinical data that proves safety, performance, and clinical benefit under MDR. Not a document you write once.
Clinical evaluation reportsThe IVDR counterpart: scientific validity, analytical performance, and clinical performance, evidenced together and maintained over the device's life.
IVD regulatoryThe PMS plan, PSUR, and PMCF loop that MDR expects to run continuously — and that Notified Bodies now audit as hard as the technical file.
EU MDR post-market surveillanceSerious incident and field safety corrective action reporting to competent authorities, on clocks that start before you have finished investigating.
Complaint handling & MDRThe European database for medical devices. The first modules became mandatory in 2026, with vigilance and post-market surveillance phasing in behind them.
EUDAMED timeline
Canada separates the product from the business that sells it. A device licence covers what you place on the market; an establishment licence covers who places it there — and for most manufacturers, both rest on an MDSAP audit.
Health Canada's licence for the device itself — required for Class II, III, and IV devices, and underwritten by your MDSAP certificate.
Global strategyThe Medical Device Single Audit Program: one QMS audit that several regulators accept. In Canada it is not optional — it is the price of a licence.
ISO 13485 & 14971The licence for the company rather than the product — importers, distributors, and Class I manufacturers. Separate from the MDL, and separately enforced.
Regulatory operationsStandards are not a fifth jurisdiction. They are the technical language underneath all of them — the evidence a 510(k) reviewer, a Notified Body, and a Health Canada auditor each expect to find, written the same way each time.
Quality management systems for medical devices — the system nearly every regulator now reads, and the backbone FDA's QMSR was rebuilt around.
ISO 13485 & 14971Risk management across the device life cycle. The file that, done properly, drives your design controls, your clinical evidence, and your labeling.
Risk managementSoftware life cycle processes for medical device software. Safety classification is the decision that sets how much process the rest of the project owes.
Healthcare technologyBasic safety and essential performance for medical electrical equipment, plus the collateral and particular standards your device type pulls in with it.
Medical device regulatoryUsability engineering. Human factors evidence that FDA and Notified Bodies both expect to see tied back to your risk file.
Design controls & DHFBiological evaluation of medical devices. Biocompatibility decided inside a risk-management process, not as a default battery of tests.
Nonclinical developmentGood clinical practice for device clinical investigations — the standard your IDE study and your MDR clinical investigation are both judged against.
Clinical quality assuranceSymbols for medical device labels. Small, and a recurring source of Notified Body findings when the symbol set drifts from the current edition.
LabelingInformation supplied by the manufacturer — what must accompany the device, harmonized so one labeling system can serve multiple markets.
Labeling
Pathway selection is not research. It is judgment built from having filed, been questioned, and been approved — and from knowing how a particular review division, Notified Body, or auditor reads the file actually in front of them.
We start with classification and route, before a document is drafted, because every hour after that inherits the call.
FDA, EU MDR and IVDR, Health Canada, and the ISO and IEC standards underneath them — held by the same senior leads, not handed between vendors.
We plan markets in an order where each filing strengthens the next, instead of paying to generate the same evidence twice.
Our leads stay through the submission, the questions, and the decision — as your regulatory leadership, not as a report you are left to action.
A pathway is a decision. These are the engagements that carry it from that decision through to an approval you can sell against.
Classification, route selection, and the submission itself — led by people who have defended these files at the Agency.
Explore FDA →Conformity under MDR and IVDR: classification, technical documentation, and the Notified Body relationship behind your CE mark.
Explore Europe →The sequencing decision — which market first, and how each filing is built so it strengthens the one after it.
Explore Global →Tell us what you have built and where you intend to sell it. We will assess the pathways genuinely open to you, flag the evidence each one would demand, and match you with a senior regulatory lead. Response within one business day. All inquiries are strictly confidential.
