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Navigating the FDA Medical Device Registration

Navigating the FDA Medical Device Registration

Are you planning to export medical devices into the U.S? Then you’ve got to understand the regulatory landscape. The regulatory landscape is governed by the Food and Drug Administration (FDA).

At the heart of FDA lies the registration process, which is a mandatory step for compliance. In this guide, we’ll look into the key aspects of FDA medical device registration to give you a roadmap to navigate the process.


What Is FDA Registration for?

FDA registration applies to businesses engaged in producing, processing, packing, or holding food, beverages, dietary supplements, or cosmetics intended for sale in the United States. Its  goal is to ensure the safety, efficacy, and quality of these products. Companies that register with the FDA demonstrate their commitment to adhering to these regulatory standards.

Who does the FDA Apply to?

The FDA’s jurisdiction include manufacturers, distributors, retailers, healthcare facilities, research institutions, importers, and food service establishments who:

  • Produce
  • Distribute
  • Sell
  • Import
  • or Handle FDA-regulated products.


In general FDA uses the 1976 Amendments provide a definition of a medical device, which is found in Section 201(h) of the FD&C Act. That is in brief words:

“A device is an instrument, apparatus, machine, implant, or in vitro reagent that diagnoses, cures, treats or prevents a disease or condition.”

You can find the complete list of establishments mandated to register and pay the fee here.

Step-by-Step Guide to FDA Medical Device Registration

Start by familiarise yourself with the FDA’s regulatory framework for medical devices. The Food and Drug Administration Amendments Act (FDAAA) of 2007 has a two-step process for submitting all registration and listing information. Firstly, you must pay the annual registration user fee. Upon payment, you can proceed to complete the registration process. Remember, your registration remains incomplete until you have:

  • Made the payment for the registration user fee
  • Electronically submitted your registration and listing information
  • Received email confirmation from the FDA indicating that all requirements have been fulfilled


Below we’ll go deeper into the guide. However, the registration can be complex and is continuously updating. Keep in mind the below guide is a simplified version that does not cover all aspects. If you need additional support, please consult our product compliance experts.

Step 1: Determine Device Classification

Begin by identifying the classification of your medical device based on its intended use and risks.

FDA Registration Classification for Medical Devices:
  • Class I devices pose minimal risk.
  • Class II devices pose moderate risk.
  • Class III devices pose high risk.


Each device class has specific regulatory requirements: Class I devices are subject to general controls, Class II devices require special controls, and Class III devices need premarket approval.

You have two primary methods to determine your device’s classification: 1) access the classification database, or if you know the device panel your device belongs to, then you can identify your device along with the corresponding regulation.

Read more about how to determine FDA Classification for medical devices here.

Step 2: Review Regulatory Controls

Learn the regulatory controls applicable to medical devices, including general controls and special controls.
The general controls apply to all device classes and encompass broad requirements such as labeling, establishment registration, and good manufacturing practices. Apart from those, there are special controls which are specific requirements tailored to certain device types or intended uses, ensuring their safety and effectiveness.

Step 3: Investigate Specific Requirements

Explore the specific regulations outlined in 21 Code of Federal Regulations (CFR) Parts 800 – 1050, which address device-specific requirements. Understand that depending on your device, you may have regulatory responsibilities outlined in various sections of the CFR.

Step 4: Consult FDA Guidance Documents or Contact HQTS Compliance Department

The FDA issues guidance documents. These documents provide detailed information and clarification on specific policies/regulation and can give you insights on topics. For example clinical trial design, device labeling, and premarket submission requirements. These are a good start to gain insights into FDA’s current thinking on regulatory matters related to medical devices. Apart from this, you can contact our compliance departments for further consultancy.

Step 5: Confirm Device Classification

Determine the classification of your medical device by identifying its intended use and physical characteristics. Understand that the classification dictates the regulatory pathway and submission requirements for bringing your device to market.

Step 6: Gather Supporting Evidence

Compile valid scientific evidence to support the safety and effectiveness of your medical device. This evidence may include preclinical, animal, and clinical testing data, as required by FDA regulations. Ensure that your supporting evidence meets FDA’s standards and provides sufficient data to demonstrate the safety and effectiveness of your device.

Step 7: Prepare Premarket Submission

Determine the most suitable premarket submission type according to your device’s classification and regulatory pathway. Keep in mind that each submission type comes with its own distinct processes, requirements, review timelines, and evidentiary burdens.

Common submission types include:

  • Investigational Device Exemption (IDE)
  • Premarket Notification (510(k))
  • Premarket Approval (PMA), De Novo
  • Humanitarian Device Exemption (HDE).

Step 8: Submit Premarket Application

Prepare and submit the premarket application to FDA according to the requirements and processes specified for your chosen submission type. Be aware of review times, evidence burden, and other factors that may impact the approval process. Ensure your submission is complete, accurate, and well-documented to expedite approval.

Conclusion: Navigating the FDA Medical Device Registration

Understanding the FDA registration process is crucial for businesses intending to export medical devices to the United States. Compliance with FDA medical device regulations ensures that your product upholds the standards for safety, efficacy, and quality.

Please keep in mind that failure to adhere to FDA registration requirements can result in severe consequences, including legal actions, fines, sanctions, or bans from regulatory authorities.

To mitigate these risks and ensure a smooth market entry, consult with our dedicated product compliance department. Our tailored guidance and support will enable your businesses to navigate the FDA registration process efficiently and effectively. Reach out to us today for expert assistance.

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