The U.S. Food and Drug Administration (FDA) has issued a draft guidance for premarket submission applications of peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters.
The draft provides proposed recommendations for class II PTA balloon catheters and class II specialty catheters, including device labeling and modifications and nonclinical performance testing, such as bench and animal testing. Comments are being accepted on the draft guidance until March 13.
