The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published a list of the guidance documents that it considers to be of the highest priority for development and publication in 2020.

The list, available from here, includes:

• The A-list: A list of prioritized device guidance documents that the Agency intends to publish during FY2020, and
• The B-list: A list of device guidance documents that the Agency intends to publish as resources permit during FY2020.

Also included, for interest, are copies of the lists of final guidance documents issued in 1980, 1990, 2000, and 2010.

CDRH is seeking public comment on the A and B lists.

The US Food and Drug Administration (FDA) has published two final guidance documents intended to provide manufacturers with information on  potential risks from certain devices, including catheters and guidewires, that are coated in materials to make introduction easier.

The guidelines are:

• 'Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations', and
• 'Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling'

Lubricious coatings help guidewires pass through introduction systems, veins and arteries more easily by reducing friction, but experience reports to FDA have shown that if the coating flakes off, it can cause adverse events including heart attack, stroke, tissue necrosis and death.