New Discussion Paper: Conveying Information about Medical Device Materials to Patients and Clinicians

U.S. Food and Drug Administration sent this bulletin at 05/20/2021 01:15 PM EDT

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FDA - Center for Devices and Radiological Health

New Discussion Paper on Conveying Information about Medical Device Materials to Patients and Healthcare Providers

Today the U.S. Food and Drug Administration (FDA) published a discussion paper, Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework. The paper is intended to help the FDA gather feedback from the public and experts on how materials information could be communicated.

This paper highlights considerations for labeling of medical devices as it relates to the inclusion of certain materials information that may be helpful in making informed decisions regarding medical device use.

 Conveying Information about Medical Device Materials to Patients and Healthcare Providers - Cover Page

Read the Discussion Paper

The FDA encourages feedback and comments which will help inform further policy development.

The FDA is accepting feedback through a public docket in the Federal Register under docket number FDA-2021-N-0334 The last day to submit comments to the docket is July 19, 2021.

Submit Comments

Questions?

If you have questions about this discussion paper, contact the Division of Industry and Consumer Education (DICE).