FDA Compliance - Techlink

US Premarket Approval (PMA)

The Food and Drug Administration (FDA) requires Premarket Approval (PMA) for Class III medical devices and some innovative technology where no identifiable predicate exists. The FDA PMA approval process is more complex and time-consuming than a 510(k) application and requires considerable preparation and resources.
There are five components to the medical device PMA approval process:

  • Pre-Investigational Device Exemption (pre-IDE)
  • Investigational Device Exemption (IDE)
  • Premarket Approval
  • Quality System Inspection to 21 CFR Part 820

FDA premarket approval process

The FDA requires clinical trials for the new devices(s) prior to submitting the premarket approval application for the new medical device. Before clinical trials can begin the manufacturer needs obtain an Investigational Device Exemption (IDE) (if the FDA considers the device to be of “significant risk”). An IDE application must include the investigational plan, as well as information on any prior clinical investigations you have conducted for your medical device. Clinical trials from outside the United States are accepted under certain circumstances.

FDA PMA and Pre-IDE meetings

Documentation requirements for an IDE application are considerable, so the FDA has established a pre-IDE process to provide preliminary review and guidance.
Techlink International Consulting, LLC can assist in drafting a Pre-IDE Protocol overview as well as prepare all necessary Pre-IDE documentation, collaborate with the manufacturer on all related clinical and non-clinical requirements and submit the application on behalf of the manufacturer.

FDA premarket approval: Final steps

After the IDE has been obtained and has Institutional Review Board (IRB) approval, the manufacturer can begin conducting clinical trials to demonstrate the device’s safety and effectiveness and then prepare the final PMA application with assistance from Techlink International Consulting, LLC. The FDA will then review the PMA application, and conduct an on-site facility and 21 CFR Part 820 quality management systems inspection. Upon successful approval of the FDA PMA application, the FDA will issue an approval letter.

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