The impact of FDA Regulations on your medical device

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:

1. Operate within a more established regulatory framework
2. Benefit from more apparent guidance documents
3. Understand expectations more precisely, particularly as an outcome of pre-submissions
4. Potentially streamline their overall global market entry process
5. Gather clinical data post-market in the US to support an EU technical documentation file for the EU CE mark
6. 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. 

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:

1. 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.
2. 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.
3. Leverage FDA guidance. The FDA provides extensive guidance documents that can inform development decisions and help avoid costly redesigns.
4. 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.
5. 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.