Change is inevitable with medical devices, suppliers, materials, and locations. All these can have an impact in the safety of the device. However, one of the more impactful changes a manufacturer can make is to any added colorants or pigments. Medical device manufacturers need to be able to assess the impact that adding colorants to their products can have on patient safety. In the webinar What Manufacturers Need to Know about Changing a Colorant in an Approved Medical Device, we will examine the unique challenges colorants pose to medical devices and FDA’s current position on changing a colorant or pigment. Specifically, we will cover the toxicological risk assessment approach that should be taken with colorants, and the choices that are currently available for chemical analysis. The possible impacts to human health and how to test to mitigate that potential will be reviewed as well. If you assess changes in a medical device, or if you have a device that has a colorant, then this information can save time and money while helping to improve the overall safety of your medical device.
By attending this webinar attendees will learn:
- When a device needs to evaluate its colorant
- What testing helps mitigate the colorants risk
- How to evaluate the colorant from a toxicological perspective