Webinar - Case Study: Material Substitutions in Devices Subject to Premarket Notification [510(k)] Using Polytetrafluoroethylene (PTFE)
Summary
On December 10, 2025, the U.S. Food and Drug Administration (FDA) held a webinar for interested parties to discuss situations where the changing of materials is required in medical devices subject to 510(k) regulations, such as polytetrafluoroethylene (PFTE) to PTFE substitutions in existing medical devices.
Background
This webinar covered PTFE material changes relating to the manufacturing of medical devices, and the requirements and principles found in the Deciding When to Submit a 510(k) for a Change to an Existing Device final guidance regarding material changes to an existing device, such as PTFE-to-PTFE substitutions.
This webinar was intended to help the medical device industry understand requirements for the substitution or changing of materials in medical devices subject to 510(k) regulation, using PTFE as an example.
Event Materials
The presentation, printable slides, and transcript are available on this webpage and at CDRH Learn under “How to Study and Market Your Device,” sub-section “Premarket Notification (510(k)).”
If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.