More Stringent Review of Implantable Pacemakers Recommended

The FDA unveiled a new draft guidance recommending that Class III implantable pacemaker pulse generators be required to submit premarket approval applications or submit notice of completion of product development protocols. 

 

"The Cardiovascular Devices Panel recommended that the implantable pacemaker pulse generator (which includes the internal pacemaker battery) be classified into Class III because the device is implanted and life-supporting and presented a potential unreasonable risk of illness or injury," the guidance finds. 

 

The FDA panel assigned to investigate pacemaker approval procedures determined that proposed standards for implantable pacemakers were not widely accepted and that premarket approval was necessary to ensure the safety and effectiveness of the devices. 

 

"FDA continues to agree with the panel's recommendation," according to the guidance. 

 

The document outlines the risks to health that the agency hopes to quell with more stringent review, such as failure to pace, improper pacing rate, arrhythmias and tissue damage. 

 

The panel recommended that PMAs be filed for the devices including detailed data on the risks identified by the agency as well as any risks not listed in the guidance, the effectiveness of the device under review and full reports of all clinical and preclinical information on safety and effectiveness. 

 

The guidance is open to public comment, and interested parties can file for recategorization of their devices.