FDA Final Guidance on Investigational Device Exemption (IDE) Categorization to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions

Today the FDA issued a final guidance, “FDA Categorization of Investigational Device Exemption Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions”, which modifies the FDA’s policy on categorization of IDE devices used in clinical studies. Devices with an approved Investigational Device Exemption (IDE) are categorized into one of two categories by FDA, Experimental (Category A) devices or Nonexperimental/Investigational (Category B) devices, based on the level of risk the device poses to the patient. This categorization is used by CMS to determine whether an IDE device, and certain services related to those devices, may be covered by CMS.

On December 2, 2015, the FDA’s Center for Devices and Radiological Health (CDRH) and CMS's Coverage and Analysis Group (CAG) executed a Memorandum of Understanding (MOU) to streamline and facilitate the categorization of investigational medical devices to support CMS’s ability to make Medicare coverage determinations for those devices. The Memorandum of Understanding (MOU) notes the need for the FDA and CMS to revise their shared understanding regarding categorization. This guidance document will further implement the MOU by describing the process and information that will be used to help the FDA determine the appropriate category for an IDE and describe when the category assigned may be changed.

The FDA will discuss the final guidance at a webinar scheduled on January 16, 2018, following a brief presentation, the FDA will respond to questions. 

Webinar Details:

Registration is not necessary.
Date: January 16, 2018
Time: 3:00 – 4:30 PM ET
To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.

To hear the presentation and ask questions dial:
In the US: 888-972-9678
International: 1-630-395-0408
Passcode: 2366523

To view the slide presentation during the webinar: 
https://www.mymeetings.com/nc/join.php?i=PWXW6320123&p=2366523&t=c

Conference number: PWXW6320123
Audience passcode: 2366523

Following the webinar, a transcript, recording and slides will be available at:http://www.fda.gov/CDRHWebinar. 

NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 ordice@fda.hhs.gov.