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Unlocking Opportunities in the World's Largest Medical Device Market

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.

Device Classification and Regulatory Pathways

Navigating US Regulations

Regulatory Authority

The U.S. Food and Drug Administration (FDA), a pivotal agency under the Department of Health and Human Services (HHS), is the cornerstone of medical device regulation in the United States. The FDA ensures the safety and effectiveness of medical devices, with the Centrer for Devices and Radiological Health (CDRH) spearheading these efforts. It is vital to be in communication with the FDA before and during the submission of medical devices for review.

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.
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.

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.

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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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