FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course
The FDA Approval Process for Medical Devices Training Course offers a detailed overview of the regulatory pathway for obtaining FDA approval in the U.S. It covers key steps such as device classification, premarket submissions (510(k), PMA), clinical trials, and post-market requirements. Participants will gain valuable insights into navigating regulatory challenges, ensuring compliance, and expediting the approval process for medical devices, making the course ideal for professionals in the medic
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States. Participants will gain an understanding of the underlying legal and regulatory requirements and the general controls applicable to all devices, including device classification, establishment registration and device listing. With the underlying framework in mind, the approval and clearance processes for new and modified devices will be presented, including 510(k), IDE, PMA, HDE and De Novo applications. Application contents, review processes, timelines, and key guidance documents will be discussed for each major type of submission. Participants will also learn about the pre-submission process, which FDA strongly recommends to help ensure the successful submission of novel devices.
Case studies will help participants to put some of the learnings into practice and to use FDA databases to research example products. The course includes up to date information which covers recent changes in legislation, regulations and guidance. Please note that the trainer has recent experience with both medical devices and in vitro diagnostics. However, please not that the course covers medical devices in general and does not provide separate sessions for specific types of medical devices (such as IVDs, software, etc).
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of attending
Upon completion of this seminar, participants will:
- Understand the overall FDA medical device regulatory process
- Know what is required for 510(k), IDE, PMA, HDE and De Novo applications
- Understand how FDA processes premarket submissions
- Identify key guidance documents to help ensure a successful process
- Determine when pre-submission interaction with FDA is recommended
- Be aware of areas of change