January 21, 2014Open Access

FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

Structured PICO

Population

Cardiac Implantable Electronic Devices (CIEDs) approved by the FDA between 1979 and 2012

Intervention

FDA Premarket Approval (PMA) pathways (original vs. supplement)

Outcome

Approval pathway utilized and requirement for new clinical data

Highlights that most new CIED models are approved via PMA supplements without new clinical data, emphasizing the critical need for robust post-market surveillance.

Abstract

Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.

FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

Structured PICO

Abstract

Cite This Study

Also Consider

Also Consider