FDA Issued Guidances with Recommendations for Performance Tests and Labeling for Guidewires

The US Food and Drug Administration (FDA) issued two final guidances laying out recommendations for performance tests and labeling for guidewires intended for use in the coronary, peripheral and neuro-vasculature, and labeling considerations for intravascular catheters, wires and delivery systems with lubricious coatings.

The two final guidances come just over a year after being released for comment in June 2018 and have been revised “as appropriate” in response to comments received during the public consultations.

The 20-page guidance on coronary, peripheral and neurovascular guidewires sets out FDA’s expectations for performance testing to support 510(k) submissions for devices falling under product codes DQX and MOF, as well as labeling recommendations for such products.

FDA notes that the guidance supersedes an earlier guidance from 1995 on coronary and cerebrovascular guidewires, in light of technological advancements made during the last two-and-a-half decades. As such, FDA says the guidance provides “updated information and additional clarity” for new or modified guidewires.

Specifically, the guidance provides recommendations for what to include in a premarket submission for guidewires, including the device description, predicate comparison, biocompatibility, sterility, pyrogenicity, shelf life and packaging, non-clinical bench testing and clinical performance testing.

The guidance also provides labeling considerations, noting that guidewires are exempt from having adequate directions for use for lay persons, and examples of modifications to a device that would require a new 510(k) to be submitted.

In the 12-page guidance on intravascular catheters, wires and delivery systems with lubricious coatings, FDA provides labeling recommendations for premarket approval (PMA) applications and 510(k) submissions. Specifically, the guidance applies to Class II devices under 23 different product codes and Class III devices under 16 product codes.

FDA says that while such devices “may offer patient benefits, recent evidence indicates that the coating may separate from intravascular devices in some circumstances,” and notes that it has reviewed serious adverse events involving hydrophilic and/or hydrophobic coatings that have led to multiple voluntary recalls of guidewires and other devices with similar coatings.

As such, FDA provides statements for manufacturers to consider adding to the labeling of their coated catheters, wires and delivery systems in light of the safety concerns related to their coatings.

The labeling considerations include adding a description of the device’s coating; specifying the regions of the vasculature the device is intended for; additional warnings and precautions; and a description of potential adverse events that could occur due to coating separation.

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