Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems; Republication
Information
Type
Rule
Regulated products
Published
February 3, 2015
Last updated
February 3, 2015
Description
Document number 2015-02049. The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled "Effective Date of Requirement for Premarket Approval for Automated External Defibrillator" that published in the Federal Register on January 29, 2015 (80 FR 4783). FDA is republishing to correct an inadvertent omission of a comment regarding adverse tissue reaction as a risk to health and the Agency's response to that comment. The final order requires the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)