Manufacturers
face critical decisions about market entry strategies because of the changing European
medical device regulations. Recent developments have created an interesting
shift in the regulatory environment, with FDA regulations offering certain
advantages over their European counterparts. In this blog, we explore the
impact of FDA regulations on medical device development and market access
strategies, providing insights for manufacturers of medical devices.
FDA vs. EU
MDR/IVDR
Due to
perceived regulatory advantages, many medical device manufacturers have
traditionally viewed Europe as their first market of entry. However, this is
shifting. Europe's Medical Device Regulation (MDR) and In Vitro Diagnostics
Regulation (IVDR) have introduced significantly more complex requirements. At
the same time, the FDA regulatory framework offers certain advantages that are
increasingly attractive to manufacturers.
The MDR/IVDR
is much more complex than FDA regulations. The modern FDA system has been
established for almost 50 years, creating a more predictable regulatory
environment with more precise expectations. This stability means manufacturers can
better understand how to get products onto the US market.
This shift in regulatory complexity is profoundly
affecting go-to-market strategies. More manufacturers, especially those with
new products, are considering entering the US market first. This approach
allows them to gather necessary clinical data under the FDA framework before
approaching the European market in a second phase.
The advantages of this approach are
numerous. By going through the FDA process first, manufacturers can:
- Operate within a more established regulatory framework
- Benefit from more apparent guidance documents
- Understand expectations more
precisely, particularly as an outcome of pre-submissions
- Potentially streamline their
overall global market entry process
- Gather clinical data post-market
in the US to support an EU technical documentation file for the EU CE mark
- We
have found that the EU has accepted study design and development
approaches that the FDA expects. Thus, efforts to satisfy the FDA also
satisfy the EU and, in most cases, other global markets.[LU1]
Advantages of FDA Regulations
One of the most significant advantages of
FDA regulations is their predictability. When a manufacturer submits to the
FDA, they face a regulatory process with:
- Clearer timelines compared to European processes
- More defined review periods and
"clock stops"
- Greater certainty around when
to expect FDA feedback/additional
information requests
- More predictable overall time-to-market estimates
From a time perspective, it's more
predictable than the European submission. The FDA typically responds within set
timeframes. When the "clock stops" for the manufacturer to address
questions, a newly defined timeframe begins upon resubmission. This
predictability allows for better resource planning and more accurate market
launch forecasting.
The importance of early regulatory strategy
Despite the
FDA pathway's comparative advantages, a critical challenge for many medical
device and IVD manufacturers is the lack of a comprehensive regulatory strategy
early in development.
Many
companies, particularly European manufacturers, introduce products to their
local market or continue with legacy devices already established in Europe.
Only later do they consider expanding to the US market. At this point, they might
face additional requirements and need to develop a different strategy.
This
reactive approach creates unnecessary complications and delays. Defining your
regulatory strategy upfront in the design phase is much easier, ensuring both
EU and US requirements are considered.
Developing a proactive FDA-focused strategy
To maximize the benefits of the FDA
regulatory pathway, manufacturers should consider these strategic approaches:
- Begin with the end in mind. Define
all target markets early in development, with special attention to FDA
requirements if the US is a priority market.
- Design for compliance. Incorporate FDA requirements
into the design process rather than attempt to retrofit devices later. In
most cases, FDA requirements are accepted by EU Notified Bodies.
- Leverage FDA guidance. The FDA
provides extensive guidance documents that can inform development
decisions and help avoid costly redesigns.
- Consider the US-first approach. Evaluate
whether the advantages of entering the US market first might benefit your
overall global strategy, particularly if clinical data generation is
required.
- Plan for global harmonization. Even
when initially focusing on FDA requirements, design your quality
management system and technical documentation to facilitate later entry
into other markets.
Strategic considerations
The impact
of FDA regulations on medical device and IVD development has evolved
significantly in recent years. What was once seen as a more challenging
regulatory environment is now, in many ways, more navigable than its European
counterpart.
The
predictability, clarity, and established nature of FDA regulations offer
strategic advantages for medical device and IVD manufacturers who approach them
proactively. By incorporating FDA regulatory considerations early in the
product development lifecycle, manufacturers can potentially accelerate their
path to market while establishing a foundation for global expansion.
The key
takeaway for medical device and IVD manufacturers is clear: develop your
regulatory strategy upfront, carefully considering FDA requirements and design
from that perspective. This approach not only streamlines your path to the US
market but may also provide advantages for your global regulatory and
commercial strategy.
If you wish to know more, you can read
about how you can collaborate with a partner on FDA submissions or contact
us.