The United States is the foremost medical device market globally, accounting for over 40% of the international market share. To legally sell in the US, medical device companies need approval from the FDA. Foreign manufacturers also need a US Agent based in the US.
Pure Global simplifies the process with AI workflows that accelerate 510(k) preparation, along with local support and representation, all for flat fees.
The U.S. medical devices market is set to reach $199B by 2025, growing at a 6.8% CAGR (2025–2032). The IVD market is valued at $41.4B in 2024, with 5.6% CAGR. Growth is driven by tech advancements, aging population (16.5% 65+), and rising healthcare spending. The sector employs ~530K people and continues expanding.
The US Food and Drug Administration (FDA) regulates medical devices and IVDs sold in the US, though the Center for Devices and Radiological Health (CDRH) is the division within FDA that is primarily responsible for device oversight. Pure Global can assist with US's medical device registration and act as your US Agent, ensuring FDA approval to sell in the American market.
Medical devices in the U.S. are meticulously classified by their medical specialty and the risk they pose to consumers. The FDA has outlined over 1,700 generic device types, organizing them into 16 medical specialties known as classification panels.
Devices are further categorized into Class I, II, and III based on risk, regulatory controls and assurance of safety and effectiveness.
Navigating the regulatory framework is crucial for market access.
We streamline your entry into the US market by:
Classifying your products to determine the best regulatory strategy.
Compiling your 510(k) or other pre-market submission and submitting to the FDA.
Acting as your US Agent includes Establishment Registration, Official Correspondent, and more, for an annual flat fee. Starting at $1,000/year.
Medical device manufacturers must implement a quality management system that fulfills the requirements of the US Quality System Regulation, which is outlined in Code of Federal Regulations Title 21 Part 820 (21 CFR Part 820). The US FDA does not recognize other quality management system certificates, though it is a participant of the Medical Device Single Audit Program (MDSAP). However, FDA has announced a revision of its quality system requirements, called the Quality Management System Regulation (QMSR), that will align more closely with ISO 13485:2016, making it easier for manufacturers with ISO 13485 certificates to comply with US QMS requirements.
Medical device classification in the US is based on substantial equivalence. You must find a legally marketed device cleared for sale by the FDA that is substantially equivalent to your own, called a predicate. Substantial equivalence is determined based on a range of factors, but mostly your device’s intended use and indications for use. Your device’s classification will match the classification of your predicate.
The US FDA De Novo process is a regulatory pathway for novel devices (i.e., devices not substantially equivalent to any legally marketed devices) that are low or moderate risk. To qualify for the De Novo process, you must demonstrate that your device is lower risk and has no predicate. Novel devices that do not qualify for the De Novo process are ruled Class III and must follow the Pre-Market Approval (PMA) submission pathway.
All medical device manufacturers and related facilities are required to pay an annual establishment registration fee to US FDA of USD 11,423 per facility.
For devices requiring 510(k) premarket notification, the applicable review fees are:
For devices submitted under the De Novo classification pathway, the review fees are:
All fees listed are government fees only and do not include consulting services, dossier preparation, testing, or regulatory representation. Fees may change without notice.
Check our Fee Calculator for up-to-date government fees in 14 markets.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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