RAPS: This course has been pre-approved by RAPS as eligible for up to 3.0 credits towards a participant's RAC recertification upon full completion.
This expert-led 3-hour webinar provides a comprehensive introduction to the key regulatory pathways for medical device submissions in the US market.
The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process.
This webinar will discuss current US Federal law on the 510(k), IDE, DeNovo, and PMA and associated requirements for getting a new or substantially changed medical device through the US FDA review process and to market in the USA. US law and the FDA require that a device be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship an investigational device to clinical investigators in many states, it must seek an exemption from that legal requirement. The IDE is the means through which the sponsor technically obtains this exemption from the FDA. The 510(k) program has recently been "modified" to encourage new technology and/or safer products to be submitted under the less severe 510(k) process to advance the state of the art, rather than the longer, more involved and more expensive PMA route when safety and efficacy issues remain substantially the same.
This expert-led 3-hour webinar provides a comprehensive introduction to the key regulatory pathways for medical device submissions in the US market.
The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process.
This webinar will discuss current US Federal law on the 510(k), IDE, DeNovo, and PMA and associated requirements for getting a new or substantially changed medical device through the US FDA review process and to market in the USA. US law and the FDA require that a device be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship an investigational device to clinical investigators in many states, it must seek an exemption from that legal requirement. The IDE is the means through which the sponsor technically obtains this exemption from the FDA. The 510(k) program has recently been "modified" to encourage new technology and/or safer products to be submitted under the less severe 510(k) process to advance the state of the art, rather than the longer, more involved and more expensive PMA route when safety and efficacy issues remain substantially the same.
Course Content
- Introduction to Device Submissions and the US FDA
- Overview of the FDA’s role in medical device regulation and the different submission pathways.
- The 510(k) Process
- Step-by-step explanation of the 510(k) premarket notification process, key requirements, and best practices.
- The IDE (Investigational Device Exemption) Process
- Understanding when and how to submit an IDE to conduct clinical investigations in the US.
- The PMA (Premarket Approval) Process
- In-depth look at the PMA process for high-risk devices, including data requirements and review steps.
- The De Novo Process
- Exploring the pathway for novel low- to moderate-risk devices that lack a predicate.
- New 510(k) Mod Program and Q-Sub Process
- Overview of the streamlined 510(k) modification program and the Q-Submission (Q-Sub) process for early FDA interactions.
- Machine Learning and Artificial Intelligence (AI) Issues - FDA Principles
- Discussion on current FDA guidance related to AI/ML-based medical devices and regulatory considerations.
- Post-Market Requirements
- Key post-market surveillance, reporting, and compliance requirements for medical devices after FDA clearance/approval.
Course Provider
John E Lincoln,
Who Should Attend
- Senior Management in Medical Devices and Combination Products
- Quality Assurance (QA) and Regulatory Affairs (RA) Professionals
- Medical Device Product Development Teams
- Research & Development (R&D) Specialists
- Engineering Teams
- Production and Manufacturing Personnel
- Operations Managers
- Marketing Professionals involved in Medical Devices
- Consultants and Others involved in:
- Drug product development
- Manufacturing processes
- Process, product, and data analysis
- Regulatory submission and compliance responsibilities
