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).
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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
MODULE 1 - Overview of US Medical Device Regulatory Principles
- Part 1 - Introduction to US FDA
- History, Structure and Mission of FDA
- Part 2 - Overview of US Regulatory Process and Pathway
- Including how to work with FDA and pre-submissions (Q-subs)
MODULE 2 - Medical Device Definition, Classification, Device Listing & Establishment Registration
- Part 1 - Medical Device Definition, Classification, Device Listing & Establishment Registration
- Part 2 - Classification Case Study
Day 2
MODULE 3 - Submissions
- Part 1 - Pre-Market Notification 510(k)
- Part 2 - De-Novo
- Automatic Class III Reclassification
- Part 3 - Pre-Market Approval (PMA)
- Part 4 - HDE & IDE (& IUO)
- Part 5 - Submission Case Study
MODULE 4 - Borderline & Combination Products
- Product Designation & Combination Products
