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FDA Proposes Rule Regarding Medical Device Reclassification: New Regulatory Definitions for Class III Devices May Prove to Be More Burdensome

Bloomberg BNA's Medical Devices Law & Industry Report
April 30, 2014

On March 25, 2014, the Food and Drug Administration (FDA) issued proposed regulations to implement the medical device classification and reclassification provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) enacted in July 2012.  FDA’s proposed rule outlines several changes though two changes appear to be truly notable regarding the current device reclassification process.  First, Section 608 of FDASIA changed the reclassification process from notice-and-comment rulemaking to proposed administrative order.  Additionally, and of concern for many manufacturers, the proposed rule also provides new regulatory definitions for Class I and Class II devices as well as substantially modifies the definition of Class III devices.  Click here to read the full article.

(Reproduced with permission from Medical Devices Law & Industry Report, 8 MELR 308, 04/30/2014. Copyright © 2014 by The Bureau of National Affairs, Inc. (800-372-1033)