Best foot forward – Pros and cons of entering the US market first
IMed Consultancy Ltd
QA/RA Medical Device & IVD Consultancy UKRP - QMS - MDR - IVDR - ISO 13485 - CE Marking - Global Submissions - UKCA
Welcome back to our new blog series dedicated to International Market Entry!
This second of four instalments will focus on the US medical devices 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%, 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.
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.
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. 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.
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.
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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.
Read more on our blog and remember to follow IMed Consultancy Ltd to stay up to date with the other blogs in this series!
[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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