What’s in Attachment G of the new FDA Biocompatibility Guidance?

The link below is for the updated FDA Biocompatibility Guidance:
➤ medicaldevicea...
The guidance was released on September 8, 2023, and the FDA conducted a live webinar on the topic on Wednesday, October 12, 2023.
There are some minor updates to the guidance, but the most significant is the addition of a new pathway for demonstrating biocompatibility when a device is for contact with intact skin and is utilizing materials that have a safe history of use with other devices.
The guidance indicates that you should first review your proposed plan for use of the Annex G pathway in a pre-submission meeting with the FDA. There are exceptions when the pathway would not be appropriate. The FDA provides a list of synthetic and natural materials that the FDA is including in this pathway. The FDA also includes a table of exclusion characteristics:
1. devices with metals that are skin contacting
2. devices stored in or containing fluids or creams
3. in-situ polymerizing materials, absorbable materials, and hydrogels,
4. contact with breached or compromised skin
5. reprocessed single-use devices
6. adhesives used to attach the device to the skin