Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems - Republication (US Food and Drug Administration Regulation) (FDA) (2018 Edition‪)‬

The Law Library presents the complete text of the Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems - Republication (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018

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).

This ebook contains:
- The complete text of the Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems - Republication (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure