The US Food and Drug Administration (FDA) requires Premarket Approval (PMA) for high-risk 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 510(k) premarket notification, and requires considerable preparation and resources.
There are five general components to the FDA PMA approval process for medical devices:
Emergo Group consultants can support each phase of your FDA PMA approval effort, including pre-submission collaboration with the FDA, clinical trial management, quality system compliance and final FDA registration.
The FDA requires clinical trials prior to submitting your premarket approval application for your medical device. Before you begin conducting clinical trials, however, you must first obtain an Investigational Device Exemption (IDE) if your device is considered “significant risk.” An IDE application must include your investigational plan, as well as information on any prior clinical investigations you have conducted for your medical device.
Documentation requirements for an IDE application are substantial, so the FDA has established the pre-submission process to provide preliminary review and guidance of your IDE documents. Issues commonly discussed during the Pre-Sub meeting with FDA reviewers include specific testing required for FDA pre-market approval applications, proposed clinical trial design and methodology, and whether your device should be designated as “significant risk” or “non-significant risk.”
As your FDA PMA consultant, Emergo Group can help you draft a Pre-Submission Protocol overview as well as prepare all necessary Pre-Submission documentation and collaborate with you on all related clinical and non-clinical requirements. Plus, we can assist you in compiling your Pre-Sub submission to the FDA and submit it on your behalf.
Once your IDE has been obtained and Institutional Review Board (IRB) approval has been granted, you may conduct clinical trials to demonstrate your device’s safety and effectiveness and then prepare your final PMA application with assistance from Emergo Group. The FDA then reviews your PMA application, and conducts an on-site facility and 21 CFR Part 820 quality management system inspection. Upon successful approval of your FDA PMA application, the FDA issues your approval letter. After obtaining FDA Establishment Registration, you may begin marketing your medical device in the US.