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.
Explore the pathwayRisk-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.
Explore the pathwayPremarket approval: the most demanding device route, reserved for Class III devices that must carry their own valid scientific evidence of safety and effectiveness.
Explore the pathwayInvestigational 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.
Explore the pathwayInvestigational 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.
Explore the pathwayNew 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.
Explore the pathwayBiologics License Application: the licensure route for biologics under the Public Health Service Act, including the 351(k) pathway for biosimilars.
Explore the pathwayEmergency 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.
Explore the pathwayExpedited development and priority review for devices addressing serious or irreversibly debilitating conditions. Earned on the strength of the clinical case, not the application.
Explore the pathwayThe expedited program for devices treating or diagnosing conditions less serious than those Breakthrough covers — the same engagement model, a different eligibility bar.
Explore the pathwayThe 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.
Explore the pathwayAnnual registration of the facilities that manufacture, repackage, or import FDA-regulated product. Unglamorous, and a standing inspection trigger when it is wrong.
Explore the pathwayThe 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.
Explore the pathwayUnique 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.
Explore the pathwayThe 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.
Explore the pathwayEurope 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.
Explore the pathwayRegulation (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.
Explore the pathwayThe 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.
Explore the pathwayThe planned, continuous appraisal of clinical data that proves safety, performance, and clinical benefit under MDR. Not a document you write once.
Explore the pathwayThe IVDR counterpart: scientific validity, analytical performance, and clinical performance, evidenced together and maintained over the device's life.
Explore the pathwayThe PMS plan, PSUR, and PMCF loop that MDR expects to run continuously — and that Notified Bodies now audit as hard as the technical file.
Explore the pathwaySerious incident and field safety corrective action reporting to competent authorities, on clocks that start before you have finished investigating.
Explore the pathwayThe European database for medical devices. The first modules became mandatory in 2026, with vigilance and post-market surveillance phasing in behind them.
Explore the pathway
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.
Explore the pathwayThe 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.
Explore the pathwayThe licence for the company rather than the product — importers, distributors, and Class I manufacturers. Separate from the MDL, and separately enforced.
Explore the pathwayStandards 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.
Explore the pathwayRisk management across the device life cycle. The file that, done properly, drives your design controls, your clinical evidence, and your labeling.
Explore the pathwaySoftware life cycle processes for medical device software. Safety classification is the decision that sets how much process the rest of the project owes.
Explore the pathwayBasic safety and essential performance for medical electrical equipment, plus the collateral and particular standards your device type pulls in with it.
Explore the pathwayUsability engineering. Human factors evidence that FDA and Notified Bodies both expect to see tied back to your risk file.
Explore the pathwayBiological evaluation of medical devices. Biocompatibility decided inside a risk-management process, not as a default battery of tests.
Explore the pathwayGood clinical practice for device clinical investigations — the standard your IDE study and your MDR clinical investigation are both judged against.
Explore the pathwaySymbols for medical device labels. Small, and a recurring source of Notified Body findings when the symbol set drifts from the current edition.
Explore the pathwayInformation supplied by the manufacturer — what must accompany the device, harmonized so one labeling system can serve multiple markets.
Explore the pathway
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.
