FDA Launches Innovative Approach to Speed Access to Certain Medical Devices
On April 23, 2014, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents entitled “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions” and “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval” (8 MELR 285, 4/30/14). Both of these guidance documents outline the FDA’s intent to further the Agency’s statutory mission to protect and promote public health. Specifically, the guidances seek to assure that patients and providers have timely and continued access to high quality medical devices that are safe and effective. Click here to read the full article.
(Reproduced with permission from Medical Devices Law & Industry Report, 8 MELR 380, 05/28/2014. Copyright © 2014 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com.)