Description

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.

Webinar Agenda – Understanding Medical Device Regulatory Pathways: 510(k), PMA & Exemptions

• 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.

Why Should You Attend:-

For decades, the regulation and control of new or substantially changed medical devices for sale in the United States (no matter where manufactured has been based on the 510(k), PMA or DeNovo submission and FDA review process. A 510(k) clearance for Class II devices or a Pre-Market Approval for Class III devices is required before commercialization. IDEs are for investigational devices before submission. And DeNovo is for less risky Class III devices that could possibly be Class II.

These submissions allow the FDA to review products as to substantial equivalence to existing products on the market (510(k)), or of a higher risk requiring clinicals (PMA). The 510(k) process has had some recent modifications to allow for newer technology (Breakthrough) or increased safety (STeP). New Machine Learning and Artificial Intelligence features add additional complexity to the process.  The data gathered during any human clinical trials of a device under an Investigational Device Exemption (IDE) becomes part of some submissions, primarily the PMA.

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.