Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin | FDA

Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin | FDA

FDA Issues Draft Guidance with Select Updates for Biocompatibility of Certain Devices that Contact Intact Skin

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. This draft guidance describes proposed recommendations to assist manufacturers in preparing the following premarket submissions for certain medical devices that come into direct contact or indirect contact with the human body:

• premarket approval applications (PMAs),
• humanitarian device exemption (HDE) applications,
• investigational device exemption (IDE) applications,
• premarket notification (510(k)) submissions, and
• De Novo classification requests (De Novo requests).

Read the Draft Guidance

After considering public comment, updates proposed by this guidance will be added to or replace applicable sections of the 2016 final guidance: Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Submit comments on this draft guidance

This draft guidance will be open for public comment for 60 days at www.Regulations.gov under docket number FDA-2013-D-0350

Submit Comments

Questions?

If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.