General country-specific regulatory information is provided on this page for medical device registration and approval in USA
Last update: December 2022

Medical Device Regulations and Classification in USA

REGULATORY AUTHORITY: The US Food and Drug Administration (FDA) is responsible for the pre-market approval of all medical devices, as well as overseeing the manufacturing, performance and safety of those.

CLASSIFICATION SYSTEM: Medical devices are divided into Classes I, II and III.

TIMEFRAME: The FDA review process takes 90 days for 510(k), 30 days for 513(g) and 180 days for PMA.

LICENSE VALIDITY: Annual establishment registration is required

AUTHORIZED REPRESENTATIVE:  A United States agent is required.

The Arazy Group medical device regulatory information and registration management technology, REGISLATE® and LICENSALE®, are designed to address each regulatory agency’s regulatory compliance requirements and Medtech registration process. These solutions are tailored to your specific medical device or IVD and the country you wish to achieve your regulatory objectives so that you will not have to invest time and resources to find that information yourself.

This comprehensive guide will walk you through the FDA registration process for medical devices and IVDs and provide you with the essential information you need to know to ensure that your product complies with the regulatory requirements.

    1. Understanding FDA Classification

The first step in the FDA registration process is to determine the classification of your medical device or IVD. The FDA has three classification categories based on the risk level associated with using the product. Class I devices have the lowest risk, while Class III devices have the highest risk.

    2. Preparing a 510(k) Submission

Once you have determined the classification of your product, you need to prepare a 510(k) submission to the FDA. A 510(k) is a premarket submission demonstrating that your device is substantially equivalent to a legally marketed device already on the market.

Your 510(k) submission should include the following components:

  • Device description
  • Indications for use
  • Device labeling
  • Performance testing data
  • Biocompatibility data
  • Sterilization data
  • Shelf-life data

    3. Preparing a PMA Application

If your medical device or IVD is classified as a Class III device, you must prepare a Premarket Approval (PMA) application. A PMA is a more comprehensive submission that includes clinical data to demonstrate the safety and effectiveness of your device.

Your PMA application should include the following components:

  • Device description
  • Indications for use
  • Device labeling
  • Clinical testing data
  • Biocompatibility data
  • Sterilization data
  • Shelf life data

    4. FDA Review Process

Once you submit your 510(k) or PMA application to the FDA, the agency will review your submission. The review process typically takes between 90 and 180 days for 510(k) submissions and between 180 and 360 days for PMA submissions.

The FDA may request additional information or clarification about your submission during the review process. Responding to these requests promptly and thoroughly is vital to ensure the review process is completed on time.

     5. Post-Market Requirements

Once the FDA has approved your medical device or IVD, you are required to comply with post-market requirements, which include the following:

  • Reporting adverse events
  • Labeling and promotional requirements
  • Establishment registration and device listing
  • Quality system regulations

Act now and leverage technology and AI to streamline and simplify your regulatory affairs objectives to obtain or maintain your product registration worldwide. Take advantage of the opportunity to optimize your time and budget, improve accuracy and compliance, and gain a competitive edge in the market.


Other North American Countries: CanadaMexico


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