To successfully bring your product to market in the United States, it’s essential to navigate the complex regulatory landscape of the US Food and Drug Administration (FDA). In this article, we’ll break down the key steps and considerations for gaining FDA approval or clearance, and provide valuable insights for companies looking to expand their reach into the US market.

Understanding the FDA’s Structure

The FDA is divided into three primary groups: biologics, devices, and drugs. Each group has its unique aspects and requirements, and companies must understand these differences to ensure a smooth approval process. Additionally, there’s a separate group for combination products, which contain more than one of these categories. This group coordinates efforts between the different departments, adding an extra layer of complexity to the process.

The Importance of Clinical Evidence

Gathering clinical evidence is a crucial step in gaining FDA approval. While many companies assume that this evidence must be collected in the US, this isn’t always the case. If your product is already on the market in your home country, you may be able to use existing clinical evidence to support your FDA application. This can be a significant advantage, as it can save time and resources.

The Need for US Support

As a foreign company, navigating the US regulatory landscape can be daunting. It’s essential to have a US-based entity, either through establishing a local presence or hiring a contract manufacturer or regulatory expert. This will help you understand the intricacies of US regulations and ensure compliance.

Key Considerations for Foreign Companies

When bringing your product to market in the US, there are several key considerations to keep in mind:

• Contract Manufacturers: With over 400 contract manufacturers in the Minneapolis area alone, there are plenty of options for companies looking to outsource production. This can help you avoid import duties and difficulties.
• US Agent: You’ll need to appoint a US agent to represent your company as the manufacturer, even if you don’t actually manufacture the product. This agent will be responsible for regulatory reporting, adverse event handling, and complaint management.
• Regulatory Expertise: Engaging a regulatory expert is crucial to navigating the complex FDA approval process. They can provide valuable guidance and support throughout the application process.

FDA Approvals Process, Timescale, and Costs

• 510(k) Clearance: For Class II medical devices, the 510(k) clearance process typically takes 3-6 months and costs between $20,000 to $50,000.
• PMA Approval: For Class III medical devices, the PMA approval process can take 1-2 years and costs between $100,000 to $500,000.
• IND and NDA: For pharmaceuticals, the IND (Investigational New Drug) application process typically takes 30 days, while the NDA (New Drug Application) process can take 1-2 years and costs between $500,000 to $1 million.
• User Fees: The FDA charges user fees for various services, including 510(k) clearance, PMA approval, and IND and NDA applications. These fees can range from $2,000 to $100,000 or more, depending on the service.

UK and European Companies: Special Considerations

As a UK or European company, you may need to consider additional factors when seeking FDA approval:

• CE Marking: While CE marking is not recognized by the FDA, it can be used to support your FDA application.
• ISO 13485: Compliance with ISO 13485, the international standard for medical device quality management systems, can also support your FDA application.
• Mutual Recognition Agreements (MRAs): The FDA has MRAs with several European countries, including the UK, which can facilitate the recognition of inspections and certifications.

Conclusion

Gaining FDA approval or clearance is a complex and time-consuming process, but with the right guidance and support, it’s achievable. By understanding the FDA’s structure, gathering clinical evidence, and having a US-based entity, foreign companies can successfully bring their products to market in the US. Remember to appoint a US agent, consider contract manufacturers, and engage a regulatory expert to ensure a smooth and successful application process.

Watch the Video

To learn more about navigating the US FDA and bringing your product to market, watch our video featuring Mark Swanson, a regulatory expert with extensive experience in the field.

About Mark Swanson

• 25+ years of experience in international regulatory and quality systems
• Expert in medical device products, including combination products and tissue-based products
• Supported 100’s of UK & European companies to successfully enter the US market & obtain FDA approvals
• Experise in FDA’s final rule for the Quality Management System Regulation (QMSR) havibng worked directly with FDA personnel on both the comparison document (AAMI TIR 102) and ISO 13485:2016.
• Active participant in international standards development and Masters program Instructor at St. Cloud State University