- January 15, 2018
07:00 PM - 07:00 PM EST
On December 4, 2017, the FDA issued a final guidance, “FDA Categorization of Investigational Device Exemption (IDE) 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.
On Tuesday, January 16, 2018, the FDA hosted a webinar for industry to discuss and answer questions about this final guidance.
Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.
As always, we appreciate your feedback; following the conclusion of the webinar, please complete a short survey about your FDA CDRH webinar experience. The survey link will be provided at the conclusion of the webinar.
NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.
Target Audience: Industry
If you have any questions, please contact CDRH's Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.