CDRH New

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 9, 2019. To view listings for other dates, see CDRH New - News and Updates.

Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations - Guidance for Industry and Food and Drug Administration Staff Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling - Guidance for Industry and Food and Drug Administration Staff CDRH Industry Basics Workshop: Custom Device Exemption and 513(g) Requests for Information Regarding the Classification of a Device - November 5, 2019 Federal Register: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings--Labeling Considerations Federal Register: Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling