USA – CDRH Draft Guidance Offers Further Info on 510(k)s for PTA, Specialty Catheters

The US Food and Drug Administration (FDA) on Friday released new draft guidance to help clarify the agency’s premarket submission recommendations for percutaneous transluminal angioplasty (PTA) catheters and specialty catheters to promote consistency across submissions.

The 27-page draft provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing these class II PTA balloon catheters and specialty catheters intended to treat lesions in the peripheral vasculature, which are veins and arteries not in the chest or abdomen.

And since the draft covers 510(k) submissions, it discusses side-by-side comparisons with predicate devices, how to determine the biocompatibility of all patient-contacting materials present in the device, how to ensure sterility (since these devices come in contact with blood), how to assess the risk of febrile reaction due to gram-negative bacterial endotoxins and/or chemicals that can leach from a device and shelf-life testing…