The US Food and Drug Administration (FDA) released the following two draft guidance documents: These guidance documents provide industry and FDA staff with recommendations on the least burdensome means of assessing the performance of catheters, guidewires, and delivery systems submitted in premarket approval applications (PMAs) or premarket notification (510(k)s).
The “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labelling” draft guidance provides draft recommendations for 510(k) submissions for certain guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance includes recommendations for descriptive characteristics, labelling, biocompatibility, sterility, non-clinical testing, and animal/clinical performance testing. When finalised, this guidance will supersede the 1995 Coronary and Cerebrovascular Guidewire Guidance.
The “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labelling Considerations” draft guidance addresses labelling considerations for devices containing lubricious coatings used in the vasculature, some of which are also within the scope of the above-referenced guidewire guidance. The guidance recommendations are based on information received and analysed by FDA concerning serious adverse events associated with hydrophilic and/or hydrophobic coatings separating (e.g., peeling, flaking, shedding, delaminating, sloughing off) from intravascular medical devices; for more details see FDA Safety Communication for Lubricious Coating Separation from Intravascular Medical Devices issued on November 23, 2015. This guidance document is intended to enhance the consistency of coating-related information in marketing submissions as well as promote the safe use of these devices in the clinical setting.