Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems
Information
Type
Rule
Regulated products
Published
January 29, 2015
Last updated
January 29, 2015
Description
Document number 2015-01619. The Food and Drug Administration (FDA or the Agency) is issuing a final order to require 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)