US Medical Device Market Entry: Key Strategies and Burdens

Responsible for approximately 50% of the estimated USD 578.75 billion global medical device market (in 2024), North America continues to dominate the medical device landscape, (source). This dominance is one of the reasons why market entry into the US is a high priority for non-US device manufacturers. Given the well-known challenges of obtaining CE marking under the EU MDR/IVDR and the FDA’s efforts to reduce entry barriers and streamline the submission process (e.g., through the eSTAR initiative), there are significant opportunities for non-US device manufacturers seeking to enter the US and its territories. 

In this article, we explore how manufacturers can lay the foundation for entry into the US market and assess the corresponding regulatory burden. We also discuss how manufacturers can leverage US marketing authorization/approval to gain access to other markets. 

Laying the Foundation for US Market Entry

Before considering the regulatory burden of entering the US market and alongside obtaining the relevant marketing authorization/approval, it is important to establish a strong foundation for market entry by focusing on three key areas: 

Reimbursement

The US healthcare reimbursement system is decentralized, involving many payer decision-makers. These include over 1,500 commercial health insurance plans (accounting for approximately 55% of all health insurance), Medicare local contractors and central offices, more than 50 Medicaid agencies, managed care networks/organizations, and other government insurance programs such as Veterans Affairs, Tricare, and the Children’s Health Insurance Program (CHIP). Both public and private payers conduct health technology assessments (HTAs) to determine the coding, coverage, and payment associated with medical procedures and the devices used in those procedures. 

The Current Procedural Terminology (CPT) coding system is the most used, though other coding systems may apply to specific types of procedures (e.g., Level II codes under the Health Care Financing Administration’s Common Procedure Coding System (HCPCS Level II)). Without reimbursement coverage, most manufacturers will encounter significant challenges in achieving adoption of their devices within the US healthcare system. 

Manufacturers can review existing codes and submit applications for new codes using resources such as the American Medical Association CPT® Smart App and Centers for Medicare & Medicaid Services (CMS) Medicare Electronic Application Request Information System™ (MEARIS™). However, given the complexities and nuances involved in obtaining a new code, it is strongly recommended that manufacturers consult qualified specialists if a new code is necessary or to identify existing codes appropriate for their device. 

Key Opinion Leaders

Alongside reimbursement, another critical factor in laying the foundation for commercial success in the US is the role of key opinion leaders (KOLs), particularly because they can significantly influence the reimbursement process. For novel technologies, KOLs often contribute to the publication of peer-reviewed literature—a key component of new reimbursement code submissions. 

Key opinion leaders also play an essential role in the development of clinical guidelines sponsored by professional associations. These guidelines may include detailed information on the benefits and risks of specific device technologies. Having an opinion leader with direct experience and knowledge of a manufacturer’s device can help ensure that relevant considerations regarding its benefits and risks are incorporated into such guidelines. 

Commercial Partners

While commercial partners typically include importers and distributors, certain types of devices may also involve user facilities. For instance, in the case of in vitro diagnostic medical devices (IVDs), there are approximately 16,000 diagnostic and medical laboratory businesses in the US. However, the Quest Diagnostics and Labcorp laboratory networks dominate the market, accounting for approximately 82% combined (36.53% and 45.85%, respectively, as of the third quarter of 2024). 

As a result, cultivating and establishing strong business relationships with such key commercial partners is absolutely critical for manufacturers of these devices. 

Assessing the US Medical Device Market Regulatory Burden 

For non-US manufacturers accustomed to regulatory frameworks in regions such as the EU or Asia, the US regulatory framework can initially seem daunting. However, the FDA has made significant efforts in recent years to reduce the regulatory burden. 

Primary Steps in Assessing US Regulatory Burdens 

1. For software as a medical device (SaMD) that is regulated as a device in other jurisdictions, determine whether its function falls under any of the excluded functions established under Section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Software subject to such exclusions will have no FDA regulatory burden, as it is excluded from the definition of a device. This determination may require consultation of relevant FDA guidance, such as the Policy for Device Software Functions and Mobile Medical Applications (issued on September 28, 2022). 

2. Determining device classification involves identifying an applicable classification regulation and the corresponding FDA product code under this regulation. Information provided under the FDA product code includes: 

• • The required submission type (e.g., 510(k) Exempt, 510(k), or Pre-Market Approval (PMA)) 
  • Applicability or exemption from Good Manufacturing Practices (GMP) (i.e., 21 CFR Part 820) (Note: Even if GMP requirements apply, certain devices listed under 21 CFR Part 820.30(a) are exempt from design controls) 
  • Eligibility for summary malfunction reporting 
  • Eligibility for third-party review 

Together with the above information, the classification regulation also indicates whether any special controls are applicable. 

3. For devices subject to the 510(k) pathway, identify potential predicate devices, as this information is mandatory for such submissions. Predicates can be identified through a search of the 510(k) Database, De Novo Database, or, in the case of down-classified devices, the PMA Database. For in vitro diagnostics (IVDs), a dual 510(k) and CLIA Waiver application may be required, depending on the nature of the IVD. 

4. For devices without an existing classification or FDA product code, or where no potential predicate device is identified for 510(k) submissions, consider reaching out to the FDA by submitting a 513(g) Request for Information. This formal response from the agency provides insight into the anticipated regulatory burden and may lead to a De Novo submission for low-to-medium risk devices. 

5. Determine eligibility of the device for FDA programs, including: 

• • Humanitarian Device Exemption Program 
  • Safety and Performance Based Pathway 
  • Breakthrough Devices Program 

6. Evaluate the applicability of other regulatory requirements to the device and the manufacturer’s Quality Management System (QMS). Examples include (but are not limited to): 

• • Electronic Records; Electronic Signatures (21 CFR Part 11) 
  • Labeling (21 CFR Part 801) 
  • Medical Device Reporting (21 CFR Part 803) 
  • Reports of Corrections and Removals (21 CFR Part 806) 
  • In Vitro Diagnostic Products for Human Use (21 CFR Part 809) 
  • Unique Device Identification (21 CFR Part 830) 
  • Radiological Health Requirements (21 CFR Parts 1000–1040) (e.g., Performance Standards for Electronic Products, Ionizing Radiation Emitting Products, Microwave and Radiofrequency Emitting Products, and Light-Emitting Products) 

This evaluation should also include a review of non-FDA regulatory requirements, such as the Health Insurance Portability and Accountability Act (HIPAA) and data breach notification requirements, which should be addressed by the manufacturer’s QMS, depending on the nature of the device. 

7. Identify relevant FDA consensus standards and apply them to the device’s design and manufacture, as applicable. This step should also involve identifying specific certification testing requirements, such as those established by the Federal Communications Commission (FCC), and any associated labeling requirements. 

8. Identify relevant FDA guidance and apply it to the device’s design and manufacture, as applicable. 

9. Determine establishment registration and device listing requirements (per 21 CFR Part 807 and summarized here). This includes identifying registration and listing obligations across the supply chain, such as for contract sterilization service providers, which are also subject to these requirements. 

Leveraging US Medical Device Market Approval in Other Markets

For manufacturers that have assessed the regulatory burden for the US market and obtained the relevant marketing authorization/approval, this can be used to facilitate entry into several other markets, most notably Australia and Singapore. 

In Australia, CE marking has historically been the most common means of obtaining device listing on the Australian Register of Therapeutic Goods (ARTG). However, since both Australia and the US are founding members of the International Medical Device Regulators Forum (IMDRF), they were involved in the development of the Medical Device Single Audit Program (MDSAP). MDSAP certification (with Australia in scope), along with appropriate evidence of obtaining FDA marketing authorization/approval, can be leveraged for ARTG listing. 

In Singapore, the US FDA is recognized by the Singapore Health Sciences Authority (HSA) as an overseas reference regulatory agency. Manufacturers that have obtained marketing authorization/approval from one or more of these overseas reference agencies may be eligible for immediate registration or for the abridged or expedited evaluation pathways. Eligible devices benefit from lower fees compared to full evaluation submissions, as well as reduced review timeframes and documentation requirements. Eligibility for these alternative evaluation pathways is outlined in current HSA guidance. 

Learn More About Regulatory Requirements for the US Medical Device Market

MedEnvoy’s regulatory experts can assist manufacturers in staying compliant with the latest US Medical Device Market regulatory requirements. Additionally, MedEnvoy has an office in the US providing US Agent services for manufacturers navigating the US medical device market.  For assistance, please reach out by clicking here, and for information about our regulatory experts, click here. 

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