CDRH Industry: Reclassification of External Cardiac Compressors and Cardiopulmonary Resuscitation Aids

Today the FDA issued a final order to reclassify external cardiac compressors (ECC) and cardiopulmonary resuscitation (CPR) aids.  An ECC is a portable device used to compress the chest periodically to provide blood flow to the heart during cardiac arrest.  The device is placed on the outside of the body near the heart and is electrically, pneumatically or manually powered.  Under the final order, ECC devices will be reclassified from class III devices to class II (special controls).  This order also creates a new classification regulation for a subgroup of devices that were previously included with this classification regulation.  The new classification – CPR aids, will reclassify CPR aids with feedback (guides to assist rescuers) to Class II and CPR aids without feedback to class I.

Under the new classifications, manufacturers will need to submit a new 510(k) for an ECC or CPR aid with feedback if they not currently on the market, or a marketed devices is about to be significantly changed or modified. Manufacturers with devices currently on the market must comply with the special controls outlined in the final order.  Manufacturers of CPR aids without feedback must comply with general controls to provide a reasonable assurance of safety and effectiveness of the device (under section 513(a) of the Federal Food, Drug and Cosmetic Act).

The FDA is issuing this final order as part of the 515 Program to ensure the appropriate regulation of Class III pre-amendments devices.

The order can be found by searching for docket number FDA-2014-752 on www.regulations.gov.