This course is intended to provide an overview of 2 FDA 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.

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 guidance 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.  FDA provides a flowchart with questions, and 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 guidance documents specifically include 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.

The attendee will learn the key aspects of the two guidance documents from FDA, including specific recommendations for how to assess the level of risk associated with the product and the change to it.  Flowcharts are reviewed that include questions for guiding the attendee through the decision process, based on type of change. The attendee will also be provided with some of the examples that the FDA uses to give guidance on what devices and/or software changes require a 501(k) and what ones do not.