The U.S. Food and Drug Administration (FDA) is responsible for regulating and overseeing the safety and effectiveness of medical devices in the United States. All medical devices sold in the U.S. must be registered with the FDA, regardless of whether they are manufactured domestically or imported.
Our FDA medical device registration service provides expert guidance and support to streamline the registration process, ensuring your device meets all regulatory requirements.
Protheragen-ING Lab's FDA registration services
Device Classification and Regulatory Pathway Analysis
Determining the correct classification for your device (Class I, II, or III) is essential. Our experts will assist in identifying the appropriate classification based on the device's intended use and risk profile.
We will help determine the most suitable regulatory pathway for your device, whether it's 510(k) premarket notification, Premarket Approval (PMA), De Novo classification request, or other applicable routes.
Establishment Registration and Device Listing
We will assist in registering your establishment with the FDA, ensuring your facility is compliant with FDA requirements. Our team will guide you through the process of listing your medical devices with the FDA, providing detailed instructions and support.
Premarket Submission Preparation
- 510(k) Submission: For devices requiring 510(k) clearance, we offer comprehensive support in preparing and submitting your premarket notification, including substantial equivalence analysis and preparation of necessary documentation.
- PMA Application: For Class III devices, we provide end-to-end support in preparing and submitting a PMA application, including clinical trial data and safety and effectiveness documentation.
- De Novo Classification: For novel devices that are low to moderate risk, we assist in preparing and submitting De Novo classification requests, enabling a streamlined pathway to market.
Labeling and Promotional Material Review
We ensure your device labeling complies with FDA requirements, including proper identification, directions for use, and necessary warnings. Our experts review your promotional materials to ensure compliance with FDA regulations, helping you avoid potential pitfalls and enforcement actions.
Quality System Regulation (QSR) Compliance
We assist in implementing Quality System Regulation (QSR) compliant quality management systems, ensuring your manufacturing processes meet FDA standards. Our team conducts internal audits to assess compliance with QSR requirements, identifying areas for improvement and ensuring readiness for FDA inspections.
Medical Device and IVD Classification Determination
To guarantee effectiveness and safety, the FDA categorizes medical devices / IVDs (in vitro diagnostic products) into three classes based on the risk and level of regulatory control needed.
| Class | Risk | Potential Harm | Regulatory Controls | Submission Type or Exemption |
| I | Lowest | Present minimal potential for harm | General | With Exemption (no registration required); Without Exemptions (510(k) clearance required) |
| II | Moderate | High risk than class I devices | General and Special (if available) | With Exemptions; Without Exemptions (510(k) Premarket Notification) |
| III | Highest | Sustain or support life, are implanted, or present potential unreasonable risk of illness or injury | General and PMA | PMA |
Ready to navigate the FDA medical device registration process with confidence? Contact us today to learn more about our services and how we can assist you in bringing your medical device to market.