FDA Medical Device Registration is a crucial step for manufacturers, distributors, and importers of medical devices looking to enter the United States market. The United States Food and Drug Administration (FDA) is responsible for safeguarding public health by regulating various consumer products, including medical devices. For companies planning to sell medical devices or in vitro diagnostic (IVD) devices in the United States, registering their products with the US FDA is a requirement. All medical devices must be registered, regardless of class.


Overview of the PMA and FDA 510(k) process


The following steps provide an overview of how the PMA and FDA 510(k) process works:

    • Determine the classification of your medical or IVD device. You can do this by searching the FDA classification database using relevant search terms or identifying a predicate device with the same intended use and technology. Pay attention to the three-letter Product Code and seven-digit Regulation Number associated with the predicate devices you identify. If you cannot determine the classification, use the 513(g) process to request classification from the FDA.

    • Implement a Quality Management System (QMS). This is required for most Class II and III devices, and some Class I devices. The QMS must meet the FDA Quality System Regulation (QSR) found in 21 CFR Part 820. Some Class I devices are exempt from most QSR requirements, with exceptions.

    • Get Pre-Submission (Pre-Sub) feedback from the FDA. This is recommended for innovative Class II and all Class III devices. Pre-Sub feedback can help to reduce the risk of delays and rejections during the review process.

    • Conduct clinical studies. This is likely to be necessary for innovative Class II and all Class III devices. You will need to apply for an Investigational Device Exemption (IDE) before conducting clinical trials. Non-significant risk studies may be performed with IRB approval.

    • Prepare and submit the Premarket Notification (510(k)) application or Premarket Approval (PMA) application. The type of application you need to submit will depend on the classification of your device. Both applications require a fee.

    • Submit to FDA facility inspections. For Class III devices, the FDA conducts facility inspections of the manufacturer and all major suppliers involved in the design and production of your device. All parties must be compliant with FDA QSR.

    • Receive PMA approval. For Class III devices, the FDA issues a PMA approval letter and posts it online.

    • Comply with FDA regulations. The FDA may conduct random inspections and issue a Form 483 for non-compliance.

    • Establish a point of contact with the FDA. This will help to ensure that you are aware of any regulatory changes and can get assistance if needed.

    • Complete Establishment Registration and Listing. This must be renewed each year between October 1st and December 31st.

    • Sell your device in the US. Once you have received FDA approval and completed establishment registration and listing, you can sell your device in the US. Your authorization does not expire as long as no changes are made to the device design, intended use, etc.


  • Regulatory Due-Diligence
  • Device Documentation – DHF, Risk Assessment documents
  • 513(g) support
  • Device Registration – 510(k) Registration
  • Device Registration -De-Novo Request for Classification
  • Device Registration – PMA Registration
  • QMS support – 21 CFR 820 Compliance or MDSAP CompliancefQA
  • Labeling support
  • Publishing and Submission support – Regulatory Consultancy services for address of deficiencies raised during the review of 510(k) application
  • Publishing support
  •  U.S. Agent
  • Q-Submission meetings
  • Commercialization support – Distributor Identification and qualification of distributor for compliance with U.S. requirements
  • Small Business Certification
  • Establishment Registration
  • Device Listing
  • Compilation of product reports and obtaining device accession numbers for Radiation Devices
  • Post Approval Change Management – major and minor changes including design changes, addition of new indications, etc.
  • Post Market Surveillance
  • UDI Compliance

Contact RABT Global today to learn more about how we can help you with your medical device regulatory needs.

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