CDRH New Update

The following new items were added to the CDRH web pages on February 15, 2019. Previous CDRH New items can be found on the CDRH New webpage.

• Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments - Draft Guidance for Industry and Food and Drug Administration Staff
• Meeting Notice: March 25-26, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
• Webcast Information: March 25-26, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
• Presentation and Transcript added to User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - February 7, 2019
• Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error
• FDA In Brief: FDA takes steps to improve communications with medical device companies concerning corrective actions in response to inspectional observations
• Federal Register: Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments