FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

ABSTRACT:

Importance

The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing.

Objective

To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process.

Design

Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each sup

SUBMITTER: Rome BN 

PROVIDER: S-EPMC4142419 | biostudies-literature | 2014 Jan 22-29

REPOSITORIES: biostudies-literature