FDA's Two New Draft Guidance on Software and Device Changes and the 510(k)

Duration: 90 Minutes
This course is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or software integrated with a device.
FDA New Draft Guidance
Instructor: Carolyn Troiano
Product ID: 501790
Objectives of the Presentation
  • To learn how to interpret and apply the two draft guidance set forth by FDA on submission of a 510(k) for changes to medical devices and/or software used in conjunction with medical devices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  • We will discuss when and how the draft guidance documents should be applied in industry
Why Should you Attend
The attendee will learn the key aspects of the two new draft guidance documents from FDA, including specific recommendations for how to assess the level of risk associated with the product and the change to it. 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.

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.

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.

The FDA notes that while neither of these drafts specifically includes combination products, the general concepts may be helpful in determining whether changes to device constituent parts of combination products need a 510(k). The guidance documents also do not address 510(k) submission requirements for remanufacturers of existing devices, such as re-processors of single-use devices.

Areas Covered
  • Medical Device changes
  • Software Application changes for software used in conjunction with medical devices
  • FDA Guidance Documents
  • FDA Enforcement
Who will Benefit
  • Information Technology Analysts, Developers and Testers for Medical Devices and Software used in conjunction with Medical Devices
  • Business Stakeholders/Subject Matter Experts
  • This webinar will also benefit any consultants working in the tobacco/e-cigarette/vapor or life science industries who are involved in developing medical devices and software
  • Note that this webinar is intended for those manufacturers who make and/or sell medical devices and/or software in the US
Topic Background
The FDA has prepared two draft guidance documents to help manufacturers of medical devices and software used in conjunction with medical devices to determine what constitutes a change or modification that requires a 510(k) submission. The intent is to provide clarity to stakeholders in industry, and to also provide examples to use as a guide for making decisions.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.
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