Medical Device- FDA & 510(k) Notifications
Know When to Submit a 510(k) Notice for a Medical Device Change
Presented By: Angela Bazigos
Pre-recorded (180 Minutes)
Understand the latest FDA guidance—or risk seizure:
Overview :

A premarket notification is required when you’re about to make a change to a legally marketed medical device subject to 510(k) requirements—whether you’re changing the design, components, manufacturing method, or intended use. But knowing exactly whether—and when—to file the notice is not straightforward. What’s more, the Food and Drug Administration (FDA) has made it clear that violations of the notification rule can result in seizures and injunctions.

Join compliance expert Angela Bazigos in this virtual boot camp as she explores the 510(k) notification process in depth. She’ll give you the latest FDA thinking to guide your when-to-submit decision making, as well as reveal the least burdensome approach to filing. Aimed at manufacturers of medical devices, this live audio event will also be valuable for lab directors and regulatory agency investigators.

After attending this audio event, you will understand what types of device changes you can make, when you’ve met the 510(k) reporting threshold, and what risk factors (such as device safety and effectiveness) to consider before you file a notice. You’ll be able to properly label changes; handle tech, engineering, and performance changes; know what constitutes a materials change; and handle in vitro diagnostic devices. If you are considering modifications to your medical devices, this is a can’t-miss event.

Session Highlights

Here is a taste of what you will uncover:

  • The main types of changes that might be made to a device
  • Labeling changes
  • Technology, engineering, and performance changes
  • Materials changes
  • Technology, engineering, performance, and materials changes for in vitro diagnostic devices (IVDs)
  • Considerations for risk-based assessments of modified devices
Session Details
Session 1: The Main Types of Changes That Might Be Made to a Device

Length: 30 Minutes

Learning Objectives: When a manufacturer modifies a device with the intent to significantly affect the safety and effectiveness of a device (for example, to significantly improve clinical outcome or to mitigate a known risk), submission of a new 510(k) is likely. Other changes, however, need to be evaluated for whether the change could significantly affect device safety and effectiveness—as well as for whether the change impacts the device substantial equivalence from the existing device.

Session 2: Labeling Changes

Length: 30 Minutes

Learning Objectives: : This session identifies several types of labeling changes or modifications to an existing device, including changes to the indications for use that can have a major impact on intended use and require submission of a new 510(k). Indications for use and using a risk-based assessment for labeling changes to help identify those changes that are more frequently recommended for documentation only are discussed.

Session 3: Technology, Engineering, and Performance Changes

Length: 30 Minutes

Learning Objectives: These types of changes encompass a broad span of design activities, from minor engineering changes in a circuit board layout to a change from electromechanical to microprocessor control of a device’s function. These changes need to be evaluated, verified, and validated according to the QS requirements. If the results of the verification and/or validation raise any unexpected issues you need to determine whether submission of a new 510(k) is required.

Session 4: Materials Changes

Length: 30 Minutes

Learning Objectives: Firms making changes to the materials from which their device is manufactured need to consider the changes discussed above and their impact on the decision regarding submission of a new 510(k). For example, a material change might also lead to a change in the labeling of the device (e.g., the removal of a contraindication or the addition of a new warning) or a change in specifications (e.g., a reduction in the strength of the device).

Session 5: Technology, Engineering, Performance, and Materials Changes for In Vitro

Length: 30 Minutes

Learning Objectives: : Changes in technology, engineering, performance, or materials of an IVD can include changes made to reagents or changes to a test method or protocol, among other things. This session will examine whether these changes require a 510(k) to be submitted, as well as whether other changes, e.g. labeling changes need to be made.

Session 6: Considerations for Risk-Based Assessments of Modified Devices

Length: 30 Minutes

Learning Objectives: This session provides guidance on the principal factors to consider in conducting a risk-based assessment to determine whether a device change leads to a significant change in the device’s risk profile.

Who Should Attend:
  • Quality managers
  • Quality engineers
  • Regulatory affairs personnel
  • Small business owners
  • GxP
  • Consultants
  • Quality vice-presidents
  • IT vice-presidents
  • Lab directors
  • Scientists
  • FDA investigators
  • Regulatory agency investigators
About Our Speaker

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / client... Read More

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