FDA New Draft Guidance on Software and Device Changes and the 510(k)

6 years ago Posted By : User Ref No: WURUR23149 0
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  • TypeWebinar
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  • Location Bakersfield, California, United States
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  • Date 03-07-2018
FDA New Draft Guidance on Software and Device Changes and the 510(k), Bakersfield, California, United States
Webinar Title
FDA New Draft Guidance on Software and Device Changes and the 510(k)
Event Type
Webinar
Webinar Date
03-07-2018
Last Date for Applying
03-07-2018
Location
Bakersfield, California, United States
Organization Name / Organize By
247compliance
Organizing/Related Departments
Marketing
Organization Type
Event Management Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Medical/Healthcare/Hospital

Location
Bakersfield, California, United States

OVERVIEW

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.


LEARNING OBJECTIVES

  • To learn how to interpret and apply the two draft guidance set forth by FDA on submission of a 510(k) for changes to medical devices and/or software used in conjunction with medical devices
  • To understand the impact this guidance will have on the development, management and use of medical devices and software used in conjunction with medical devices that have been modified
  • The course will provide useful information to medical device and software developers who manage changes to these devices and/or software
  • The audience will learn what device changes and/or software changes will likely require the submission of a 510(k) and what ones will not
  • We will discuss when and how the draft guidance documents should be applied in industry


 

AREAS COVERED

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


WHO WILL BENEFITS?

  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • 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
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above

 

SPEAKER

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation

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Time: 01:00 PM EST| 10:00 AM PST

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