FDA Reclassifies Cardiovascular Compressor Devices

The FDA is reclassifying external cardiac compressors from Class III, which requires premarket approval, to Class II devices.

Cardiopulmonary resuscitation (CPR) aids, will also be reclassified from Class III to Class II, according to a final order issued May 25.

Reclassification of both devices is supported by their safe history of use and the need for such devices in situations with inadequate access to professionally trained rescuers.

The FDA also revised the device labeling special controls section to clarify intended use as an addition to manual CPR.

The agency proposed a reclassification of the devices in January 2013, requesting comments from industry stakeholders. In September 2013, the Circulatory System Devices panel recommended the devices be reclassified into Class II. The committee recommended CPR aid devices without feedback be reclassified into Class I because general controls were sufficient.

FDA refined special controls by adding requirements for automated ECC devices, including performance testing of the time necessary to deploy the device and additional labeling requirements.

Manufacturers of ECC devices and CPR aid devices with feedback that have not been legally marketed prior to the effective date of the final order, or models that have been legally marketed but are required to submit a new 510(k) must demonstrate compliance with the special controls included in the final order, before marketing the new or changed device.

The final order can be found here: www.fdanews.com/05-25-16-ReclassificationCardiovascularDevices.pdf. — Joya Patel