Best foot forward – Pros and cons of entering the US market first

by | Apr 22, 2024 | New Markets, USA

New markets - Mexico

Welcome back to our new blog series dedicated to International Market Entry!

IMed’s team will look at three major markets for medical devices- the EU, the UK and the USA- highlighting some key considerations relating to entering each of these geographies “first” to help manufacturers make informed decisions and successfully expand the global presence of their products.

Head over to our previous blog<link> to dive into the current global regulatory scenario and its opportunities.

This second of four instalments will focus on the US medical devices market.

The US medical device market

The U.S. medical device market size was valued at USD 176.7 billion in 2020 and is anticipated to exhibit a compound annual growth rate (CAGR) of 5.0% over the forecast period, according to Grandview Research.[i] It is not surprising therefore that many medical device manufacturers are keen to abandon their preconceptions over FDA strictures and initiate their market entry by launching on the US market first of all.

Regulatory routes for medical devices in the US

For the majority of medium risk devices, the typical regulatory route is the submission of a 510 (k) registration. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective as an already legally marketed device and doesn’t raise new questions on safety and effectiveness. A route for novel devices also exists, where the product is not able to demonstrate similarity to an existing legally marketed device which is called a De Novo submission.

Lower risk devices require registration and listing with FDA, but are often exempt from formal regulatory submission to FDA prior to being placed in the USA market.

Higher risk devices are usually considered via a pre-market approval (PMA) route, which is similar in approach and evidence requirements to UK and EU Class III medical device certification.

Substantial Equivalence – a quicker way to market

While the US is a tough market to enter first with a very innovative, high-risk product, if there is an existing, similar product- an equivalent device with the same intended use- submission is vastly simplified.

While the device developer needs to ensure their QMS meets FDA requirements (21 CFR Part 820), overall regulatory approval fees are usually considerably lower than in the EU for product assessment.

The manufacturer must use their development documentation to support their argument of substantial equivalence when writing the 510(k) which needs to be carried out in line with publicly available FDA guidance. FDA will follow specific timings for response and in case of a positive outcome the manufacturer will receive a letter confirming that the device is indeed substantially equivalent.  In addition to this, if the manufacturer is able to prove that the device is substantially equivalent a clinical investigation isn’t always necessary when using the 510(k)-submission route, helping to reduce time-to-market and overall costs.

Contrary to this, if the manufacturer receives a Not Substantially Equivalent (NSE) letter they will have to restart the process identifying either a new predicate device or a new submission type.

Understanding the FDA (Food & Drug Administration)

The FDA have a very different way of operating to EU authorities, so understanding of FDA procedural and cultural expectations is important for successful interaction. While manufacturers who successfully find a suitable predicate will have a reasonably easy and pain-free experience, innovative devices may need to follow a more complex process, called De-Novo. The De-Novo process looks to qualify and classify a new product type and determine the special controls necessary to demonstrate safety and performance. Following De-Novo approval, the new device can in fact become the predicate for future product submissions in the USA under the 510(k) route.

Choosing the right market for your medical device

In this complex environment it is hardly surprising that medical device manufacturers with new devices, or that want to expand into new territories, are confused. Costs, timelines, shifting deadlines and potential extensions, these are all elements of uncertainty that make the decision regarding market entry, and particularly which market to enter first, highly complex.

There is of course no clear-cut answer for medical device manufacturers evaluating which market to enter first, but understanding the strengths and weaknesses of the regulatory systems currently active in these major markets can help frame the decision-making process.

Without a doubt, device maturity, therapeutic area and classification will drive the selection of the market most likely to yield success, but venturing forth without experienced guidance and advice means taking unnecessary risks in what is currently a changing and complex regulatory landscape.

The importance of relying on international regulatory experts

Securing the support of international regulatory experts will not only help navigate the complexities of specific markets, managing the expectations of their authorities efficiently and rapidly, but can help identify areas of overlap between the different geographies’ requirements to help structure longer term expansion strategies.

Read more about it on our white paper, available on our Resources page, or contact the team at IMed Consultancy for deeper insight into the UK, US and EU regulatory scenarios: hello@imedconsultancy.com.

[i] Grandview Research, U.S. Medical Device Manufacturers Market Size, Share & Trends Analysis Report By Type (Diagnostic Imaging, Consumables, Patient Aids, Orthopedics), And Segment Forecasts, 2021 – 2028,

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