top of page

[FDA News] October 12th Webinar_Use of ISO 10993-1 (Biocompatibility) Final Guidance

fda biocompatibility final guidance iso 10993-1

The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the final guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."

· Date: October 12, 2023

· Time: 1:00 to 2:30 p.m. (ET)

Topics to be covered in the FDA webinar:

  • Provide an overview of the new Attachment G, which describes a new policy for certain devices that contact intact skin including:

- the types of devices, components, and materials included in the policy

- recommendations for what information and labeling should be provided in premarket submissions

  • Explain related changes made to the electronic Submission Template and Resource (eSTAR) form

  • Answer questions about the final guidance and eSTAR changes.

Please refer to the following for details on how to join the webinar and for more information.

provision consulting group

Provision work professionally while meeting clients' needs.

We will streamline the regulatory processes so that our clients can utilize their time

and money most efficiently.

Experience the best FDA approval directions and solutions!

If you have questions about FDA regulation of Medical Devicese,

OTC Drugs, Cosmetic or importing of medical devices to the United States,

please CONTACT US,

Office 1-909-493-3276


Post: Blog2_Post
bottom of page