2018 Update -FDA's Two New Draft Guidance on Software and Device Changes and the 510(k)

Product Id : FDA126
Instructor : Carolyn Troiano
May 22, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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Medical Device- FDA & 510(k) notifications Know When to Submit a 510(k) Notice for a Medical Device Change

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:

  • Labeling
  • Technology, Engineering and Performance
  • Materials
  • Technology, Engineering, Performance and Materials for in vitro Diagnostic Devices

The second FDA guidance addresses proposed changes to software used in conjunction with a medical device. The draft includes modifications made to correct software defects, provide patches or updates to code, and provide enhancements or modifications to functionality. Software manufacturers must determine whether any change or modification could potentially and significantly affect the safety or effectiveness of a device. The first step recommended by FDA is to conduct a risk assessment of the change, including all potential new risks along with known risks for the device. Again, the FDA provides a flowchart to guide software manufacturers through the process of determining whether a 510(k) must be prepared. FDA also provides examples of changes to software, along with an analysis as to why a new 510(k) would or would not be needed.

Why Should You Attend:

Anyone who is involved in software and device design, modification, manufacturing, quality testing and distribution should be aware of these changes and the impact on decision-making as to whether or not to prepare a new 510(k). The FDA provides flowcharts that guide the reader to the best decision, but some judgment is also required. The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review. This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness. After attending this webinar, you will be able to better navigate the processes required to determine how to manage software and device changes in an FDA-compliant manner.

Areas Covered in the Session:

  • Medical Device changes
  • Software Application changes for software used in conjunction with medical devices
  • FDA Guidance Documents
  • FDA Enforcement
  • New 510(k) submission
  • Flowcharts for decision-making related to specific changes:
    • Labeling
    • Technology, Engineering and Performance
    • Materials
  • Q&A

Who Will Benefit:

  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Quality Managers, Chemists and Microbiologists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Consultants in the Life Sciences and Tobacco Industries
Speaker Profile:

Carolyn Troiano has vast experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, in which she has worked as a consultant for over 30 years. She has provided services to many large pharmaceutical and tobacco companies throughout the US and Europe. As part of her services, she has helped develop and execute compliance strategies and programs.

Carolyn also has experience in supply chain security and compliance, which includes technologies and procedures for improving the protection of companies’ brand integrity. At present, she is active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI).


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