Our Medical Device Listing & Classification Support Services guide manufacturers, importers, and distributors through the FDA’s regulatory framework, ensuring timely market entry and ongoing compliance with 21 CFR Part 807
The FDA classifies medical devices based on risk level and regulatory controls. Accurate classification determines the regulatory requirements, including:
Failure to comply can lead to:
Our services ensure accurate classification, timely device listing, and ongoing FDA compliance for uninterrupted market access.
We help you determine the correct classification of your medical device (Class I, II, or III) based on intended use, risk profile, and specific FDA regulatory requirements.
Medical devices in the U.S. must be listed with the FDA under the manufacturer’s or importer’s establishment registration. We manage the listing process, submissions and annual renewals.
For most Class II medical devices, a 510(k) Premarket Notification is required to demonstrate substantial equivalence to legally marketed devices. We guide you through the 510(k) submission process.
Class III medical devices, which pose the highest risk, typically require Premarket Approval (PMA). We provide strategic PMA consulting to navigate this complex submission process.
Some Class I and Class II medical devices are exempt from certain regulatory controls. We assess your device’s eligibility for exemptions, saving you time and costs.
FDA-compliant labeling and Unique Device Identification (UDI) are critical for medical device traceability and post-market safety. We ensure all labeling requirements are met.
pecialists in 21 CFR Part 807, 510(k) submissions, and PMA pathways.
We ensure correct device classification, avoiding regulatory delays and market disruptions.
From initial classification assessments to device listing, 510(k) submissions, and labeling compliance.
Comprehensive U.S. Agent services for foreign manufacturers seeking U.S. market access.
Read what our clients have to say about our services and how we have helped them export product.
The FDA classifies devices based on risk:
A 510(k) Premarket Notification demonstrates that a Class II device is substantially equivalent to an already legally marketed device. It is required before commercial distribution in the U.S.
The Unique Device Identification (UDI) system:
Yes. Foreign medical device manufacturers must appoint a U.S. Agent for:
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Navigating the FDA’s medical device regulations requires precision, expertise, and strategic planning. Our Medical Device Listing & Classification Support Services ensure accurate device classification, timely FDA listing, and full compliance with U.S. market regulations, enabling you to launch products faster and avoid costly compliance issues.
Our friendly team is always happy to help and will reach out as soon as possible.
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