United States

FDA US Medical Device Registration

The United States, with a population nearing 340 million, stands as the foremost medical device market globally, accounting for over 40% of the international market share. Its continuous growth spells abundant opportunities for medical device companies worldwide seeking US FDA medical device registration.

Device Classification and Regulatory Pathways

Navigating US Regulations

Regulatory Authority

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.

Classification

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.

Key Requirements

Navigating the regulatory framework is crucial for market access.

Class I devices, are those for which compliance with general controls provide reasonable assurance of safety and effectiveness. These typically require registration only.
Class II devices, are those which require special controls in order to provide reasonable assurance of safety and effectiveness. Filing of Pre-Market Notification or 510(k) submission are necessary.
Class III devices, are those which are used to support or sustain human life or other important functions. These require submission and approval of a Premarket Approval Application (PMA).
Foreign manufacturers must appoint a US Agent (only one agent is designated by the manufacturer), who acts as the official correspondent in order to facilitate communications with the FDA. The US Agent reside or maintain a place of business in the United States.

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How We Can Help

Tailored Support for Market Entry

We streamline your entry into the U.S. market by:

Classifying your products to determine the appropriate regulatory pathway.
Compiling and submitting necessary documentation.
Serving as your US Agent to liaise with the FDA, managing all communication and post-market follow-up requirements.

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Frequently
Asked Questions

What are the medical device quality management system requirements in the US?

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.

How do I classify my medical device in the US?

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.

How do I sell my device in the US if my device has no 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.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.