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How to access the U.S. market with your medical device

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How to access the U.S. market with your medical device

26.10.2023

In one of our latest Venture Mentoring events by Basel Are Business & Innovation, we invited Nila-Pia Rähle to speak on market access for medical devices and in-vitro diagnostics products in the US. She is co-founder and president of the board of our partner Effectum Medical and has over 20 years of experience working in the field of medical devices.

Impressions of the event

Meet Effectum Medical

Effectum Medical specializing in regulatory affairs and quality management in the medtech industry. The company serves as a trusted partner for medical device startups and established firms alike, guiding them through the complex landscape of global regulatory requirements.

Two service models serve this mission:

Meet Nila-Pia Rähle

The European challenge

Unlike the FDA’s more interactive approach, the European system is difficult and time-consuming to navigate for startups. This complexity can be particularly daunting for startups that don’t have in-house regulatory expertise.

Nila-Pia mentions two more pressing issues.

Delayed Notified Bodies

Notified Bodies, the organisations designated by an EU country to assess the conformity of certain products before being placed on the market, are currently delayed. It takes anywhere between 13 to 18 months just for the technical documentation review.

Lack of guidance

Unlike the FDA, which provides pre-submission meetings and direct feedback to make sure your application is done right, European Notified Bodies generally don’t offer any guidance prior to your submission. This makes the already complex process even more challenging, leaving your startup to navigate the regulatory maze on its own.

 

The advantages of the United States

The United State’s FDA (Food and Drug Administration) offers a simpler, interactive approach. This provides startups that go to market in the US with distinct advantages.

1. Risk-based approach

The FDA categorizes devices into three classes based on their potential risk to patients.

  • Class I: Low-risk devices that generally don’t require premarket approval and are subject to general controls like proper labeling.
  • Class II: Moderate-risk devices that often require special controls and may need premarket notification (510k).
  • Class III: High-risk, often life-supporting or life-sustaining devices that usually require premarket approval (PMA) involving rigorous testing and clinical trials.

2. Pre-submission meetings

The FDA gives you the opportunity for a pre-submission meeting. This meeting allows startups to engage directly with the FDA to discuss their regulatory strategy, ask questions and receive feedback. It helps you tailor your submission to meet all requirements on the first try, reducing the likelihood of delays due to incomplete or incorrect submissions.

3. Simplified approval process

The FDA makes use of a concept called “predicate devices”. These are existing devices that are already marketed in the US and serve as a benchmark for new devices seeking FDA clearance. If you can show that your new device is substantially equivalent to an existing, already marketed device, you can often bypass some of the more rigorous testing requirements and bring your product to market significantly faster.

How to apply for U.S. market access with your medical device

 

Step 1: Ensure the U.S. is the right market for your startup

Evaluate whether the U.S. is really the place you want to go to market in. Be prepared for a highly competitive medical device market with many established and emerging companies vying for market share. Clinical studies might also be more costly than in Europe.

Step 2: Classify your device

Each of the three previously mentioned classes has its own set of regulatory requirements, with Class III being the most stringent due to the higher level of risk associated with these devices. Understanding your device’s classification will help you identify the appropriate regulatory pathway you’ll need to follow.

Step 3: Consult with FDA

Consult with the FDA through a pre-submission meeting. The FDA offers this service free of charge and it provides an opportunity to discuss your device’s regulatory and clinical strategy. This can help you tailor your submissions more precisely and avoid faulty submissions.

Step 4: Choose the right submission pathway

During this meeting, you’ll also learn what type of application is right for your device:

  • 510(k): Pre-market notification for Class I and Class II devices, used to demonstrate that the device is substantially equivalent to an already marketed (predicate) device.
  • 510(k) Exempt: Some Class I and a few Class II devices are exempt from the 510(k) pre-market notification requirement because they are considered to be of lower risk and have a well-understood safety profile.
  • PMA (Pre-Market Approval): Required for Class III devices, this is the most rigorous type of application involving clinical trials to prove safety and effectiveness.
  • HDE (Humanitarian Device Exemption): Devices that are intended to benefit patients with rare conditions (affecting fewer than 8,000 individuals in the U.S. per year) may be approved without needing to demonstrate effectiveness, but they must prove safety and that the probable benefit outweighs the risk.
  • De Novo Classification Request: For low to moderate risk devices that do not have a predicate, this request seeks FDA classification into Class I or II.

Step 5: Prepare documentation

Preparing all the necessary technical documentation can include your device’s specifications, test results and clinical data, if applicable. If you’re going for a 510(k) submission, you’ll also need to identify a predicate device to demonstrate that your device is substantially equivalent to an existing, approved product. Make sure to also have a quality management system in place, as this is a requirement for all classes of medical devices.

Step 6: Register and submit

Your final step is to register your company and product with the FDA. This is a prerequisite for submitting any type of application for product approval. If you’re not not living in the U.S., you need a U.S. agent to represent your company (they must be able to answer questions from the FDA about your device).

The costs of bringing a medical device to the US market

While some aspects, like pre-submission meetings, are currently free of charge, other steps in the process can be costly. These may include fees for submitting applications, costs for clinical trials and expenses related to compiling the necessary documentation.

While most of those costs vary, the FDA publishes its application costs on its website:

* A small business is defined as a business, including its affiliates, whose gross receipts
and sales are less than $100 million for the most recent tax year.

For the most recent information, visit the FDA’s Medical Device User Fee Amendments.

FDA clearance/approval could help with access in the EU

FDA clearance/approval not only facilitates U.S. market entry but also eases global expansion.

Some countries’ regulating bodies have agreements with the FDA, allowing for easier approval of FDA cleared or approved products. This is very helpful for startups aiming for global expansion as it saves them from undergoing multiple full approval processes.

Switzerland, for example, is currently evaluating streamlining the entry of FDA-approved products, offering a quicker and more cost-effective route to market.

Need help?
If you need help bringing your medical device to market, get in touch with our Venture Mentoring team.

We provide unbiased, professional advice to startups and entrepreneurs, looking to turn their invention into a successful business.

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