News | Cardiovascular Business | December 19, 2017

FDA Issues Final Guidance on Investigational Device Exemption Categorization

Document acts as follow-up to 2015 Memorandum of Understanding to assist CMS with coverage decisions

FDA Issues Final Guidance on Investigational Device Exemption Categorization

December 19, 2017 — The U.S. Food and Drug Administration (FDA) recently 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 the 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 Dec. 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. The new 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 Jan. 16, 2018 from 3:00-4:30 p.m. ET. The agency will respond to questions following a brief presentation.

For more information: www.fda.gov

Related Content

GlobalData: Amazon Poised to Make Huge Strides in Healthcare
News | Cardiovascular Business | August 31, 2018
A new report from data and analytics company GlobalData suggests that Amazon is poised to make huge strides in...
CMS Proposes Overhaul of Medicare's Accountable Care Organization Program
News | Cardiovascular Business | August 09, 2018
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule August 9 that would overhaul the Medicare...
ECRI Institute Announces New Clinical Guideline Repository Website
News | Cardiovascular Business | July 27, 2018
July 27, 2018 — Following the deactivation of the National Guideline Clearinghouse (NGC) by the Agency for Healthcare
FDA Releases New Report Assessing Quality, Safety and Effectiveness of Medical Device Servicing
News | Cardiovascular Business | June 07, 2018
A new report from the U.S. Food and Drug Administration (FDA) discusses the continued quality, safety and effectiveness...
DAIC Editor Dave Fornell won the 2018 AZBEE national silver award for best blog for "The Future of Cardiology: 17 Technologies to Watch. DAIC magazine - diagnostic and interventional cardiology magazine.
News | Cardiovascular Business | May 14, 2018
May 14, 2018 — Diagnostic and Interventional Cardiology (DAIC) magazine was honored with a ...
FDA Announces New Medical Device Safety Action Plan
News | Cardiovascular Business | April 25, 2018
The U.S. Food and Drug Administration (FDA) released a new Medical Device Safety Action Plan outlining how the agency...
DAIC Wins Two 2018 Regional Azbee Awards for Editorial Excellence
Feature | Cardiovascular Business | April 20, 2018
Diagnostic and Interventional Cardiology was honored with a pair of Azbee Awards for editorial excellence at the 2018...
DAIC Editor Dave Fornell displays the 2018 Neal Award for Best Use of Social Media
News | Cardiovascular Business | April 05, 2018
April 5, 2018 — Diagnostic and Interventional Cardiology (DAIC) magazine received the 2018 Jesse H.
Veritas Capital Acquiring Three Software Units from GE Healthcare
News | Cardiovascular Business | April 02, 2018
GE Healthcare announced the sale of its Value-Based Care Division — including its software assets for Enterprise...
The annual Azbee Awards are hosted by the American Society of Business Publication Editors (ASBPE) to recognize editorial and design excellence in the business, trade and specialty press. Dave Fornell won blog award for DAIC
News | Cardiovascular Business | March 08, 2018
Scranton Gillette Communications’ Diagnostic and Interventional Cardiology (DAIC) was recently named a 2018
Overlay Init