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Zdrowie i gospodarka · 1/8/2013

Cardiovascular Devices; Reclassification of External Cardiac Compressor

The Food and Drug Administration (FDA) is proposing to reclassify the external cardiac compressor, including cardiopulmonary resuscitation (CPR) aids, from class III devices into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →