Entering the US Healthcare Market

FDA Announcements & Town Hall Meeting Summaries

From the weekly Town Hall Meetings hosted by the US FDA, our team translates and condenses the important points and guidances to provide an efficient way to keep you up-to-date.

The US healthcare market is a complex, fragmented space. Our guide and checklist will facilitate a soft-landing to help grow you business the right way in the United States.

Meeting the unmet need:

The key to success in US market entry is picking the right commercial partners, says Ernesto Chanona, Director of Business Development at CSSi LifeSciences.

The first half of 2021 has seen more investment into the biotechnology sector than in the entire year of 2019, as reported by the Silicon Valley Bank.  It is an excellent time to be in the life sciences sector, and as such, many would like to take the necessary steps to enter the US market by obtaining regulatory approval for medical devices, diagnostics, biologics, vaccines or drugs. As it stands, currently 35% of approved medical devices in the United States, 40% of finished pharmaceutical drugs for the United States, and 80% of APIs (active pharmaceutical ingredients) are manufactured or compounded from foreign entities. While entering the US market can be a tedious and costly task, the great news is success and commercialization are an attainable goal for those who seek to understand the process. Many companies who are not properly prepared can find themselves having difficulty crossing the all too well-known valley of death. Seeing the success of other companies proves, though, that there is a pathway to the other side of the valley. The question is, where does one take the first step to begin their US market entrance journey?

First, companies need to ensure that they are prepared before they take their first step. When entering the US market, foreign companies should spend time on market and revenue research, creating a comprehensive project timeline, and estimating costs. As this process unfolds, there are a few questions to consider:

  • What unmet public need are we solving with this product?
  • Are we planning to launch our product in multiple markets?
  • How much should our product cost in each market?
  • Are we seeking dilutive capital from US investors to support regulatory approval and commercialization?
  • Do I meet all regulations and requirements required by the FDA?
  • How do I establish a business in the US?
  • Who are the stakeholders (economic development, academic, government, services) in our US biotech hub that could support my company and my technology?

These questions are best answered by a consulting team who has made this journey already, and who has in-depth knowledge of the path ahead. Picking the right partners is the key to commercial success, whether it be to out-license or sell a technology, or find the right distribution partners for entering the hospital supply chains in the US.    As a foreign company looking to enter the US market, designating a United States agent is required by the FDA. They must reside at a US address and will act as a liaison between the FDA and the life sciences company. Selecting the right US Agent liaison can best position a company for a swift and cost-effective regulatory approval, connectivity to supportive partners and investors, and the successful accomplishment of commercialization goals within the allotted timeframe and budget.

In the case of medical device companies, for instance, the regulatory requirements that need to be met include a Quality Management System that meets US standards, approval through the appropriate filing process with the FDA, and annual reporting and registration. There are four common types of premarket submissions: 510(k) (Premarket Notification), PMA (Premarket Approval), De Novo Classification Request, and HDE (Humanitarian Device Exemption).  The regulatory path that a device depends on the case that is made to the FDA. Your regulatory consultant will write and deliver the case to the FDA and obtain the agency’s buy-in to secure the swiftest, most affordable path forward. Some of the questions they will answer include:

  • What submission is best for my device?
  • What is the most suitable indication?
  • Is a clinical trial required? How extensive?
  • Are we eligible for any special designations from the FDA?

Investor relations is another important aspect to successfully commercializing technology in the United States. Finding the group with an investment thesis that aligns with your technology and goals can be challenging. Moreover, understanding the needs of the American investor community is not always straightforward. In short, investors want to see clearly defined milestones and the costs associated with them. The team should be able to elaborate on the rationale behind the costs assigned to aspects such as manufacturing, FDA submissions, and testing. The timeline for the return on investment should also be clearly defined. By understanding your technology and the FDA requirements, your regulatory team will be able to generate this information, further de-risking your technology to investor groups.

There are many moving pieces to the US market entry process and having a strong team to support each piece is the key to commercialization success. While the entirety of this process can be overwhelming for companies who are not specialized in it, collaboration and partnerships with experienced consultants and organizations can give foreign life sciences companies the counsel and expertise needed to make the journey more navigable. Proper guidance makes any FDA entry journey, no matter how challenging, achievable.

FDA Submissions

There are several ways to submit a product to the FDA for premarket approval. Two of the most well-known methods are the 510(k) premarket notification and the PMA premarket approval. The less frequently used De Novo submission is another option. These submissions result in a decision from the FDA that grants marketing authorization, either through clearance [510(k)], approval [PMA], or De Novo clearance [De Novo]. Additionally, there are other forms of premarket submissions to the FDA, such as Pre-submissions, IDE (Investigational Device Exemptions), HDE (Humanitarian Device Exemptions), and Master Files. The most popular submissions are explained in further detail below.

510(K) Submissions

To legally sell a Class I, II, or III device intended for human use in the US, a Premarket Approval (PMA) is not always necessary. In these cases, the manufacturer must submit a 510(k) to the FDA unless the product is exempt from the requirements specified in the Federal Food, Drug, and Cosmetic Act and doesn’t exceed the exemptions listed in sections .9 of the device classification regulation chapters (e.g. 21 CFR 862.9, 21 CFR 864.9). The 510(k) is a premarket submission to the FDA that aims to demonstrate that the device is at least as safe and effective as a device that is already legally sold and not subject to PMA. The manufacturer must compare their device to similar products already on the market and provide evidence to support their claims of substantial equivalency. Marketing of the device cannot commence until the FDA gives the go-ahead, which is signified by an order declaring the device as substantially equivalent (SE). Once the device is deemed SE, it can then be sold in the US.


The Premarket Approval (PMA) process is a thorough scientific and regulatory review conducted by the FDA to assess the safety and effectiveness of Class III medical devices. These devices, which are deemed to have the highest level of risk, are crucial for supporting or maintaining human life, preventing health impairment, or posing a potential risk of injury or illness. Given the level of danger associated with Class III devices, the FDA determines that general and special controls are not enough to ensure their safety and effectiveness. Thus, these products must go through the PMA application process outlined in section 515 of the FD&C Act before they can be marketed. It’s worth noting that some Class III preamendment devices may require a Class III 510(k). PMA submissions typically contain technical sections, including non-clinical laboratory studies and clinical investigations, and an inspection of the facility is often required to ensure compliance with 21 CFR 820 prior to approval.

De Novo

The De Novo pathway provides a solution for marketing novel, low- to moderate-risk devices that lack a recognized predicate device. Upon the successful evaluation of a De Novo submission, the FDA will create a classification for the device, establish necessary regulations, and determine the special controls necessary for future premarket submissions of similar devices. Companies with low- to moderate-risk novel devices have two options when considering the De Novo pathway. They can either submit a 510(k) to the FDA and, if they receive a “Not Substantially Equivalent” determination, request a De Novo review, or they can skip the 510(k) submission and proceed directly with a De Novo request. Devices that go through the De Novo process can be marketed and serve as predicates for future 510(k) submissions.

Pre-Submission (Pre-Subs)

The Pre-submission process to the FDA serves as a means for obtaining feedback and guidance on a device before its formal submission for marketing clearance. This process can be utilized for a variety of reasons, including meeting requests, assessing risk, addressing submission-related issues, and seeking answers to specific questions pertaining to a future submission or study protocol. The Pre-Sub Program, previously referred to as the Pre-IDE Program, offers sponsors the opportunity to receive input from the FDA before submitting an IDE or marketing application. It also provides a channel for the Agency to offer guidance on the development of protocols for non-significant risk (NSR) device studies or those conducted outside of the U.S. to support future marketing efforts. The Pre-Sub program therefore represents an effective path to market while also supporting the FDA’s mission of promoting new medical device innovations.

For any questions or support needs, please contact
Damian Daszynski at ddaszynski@cssilifesciences.com