Newsletter - January 20, 2022
FDA Provides Suggestions for Point-of-Care 3D Printing of Devices
Several 3D printed devices may be printed at the clinic rather than printed at a traditional manufacturing facility and shipped. But 3D printing operations still need to comply with FDA’s QSR and GMP requirements. FDA released a Discussion Paper listing three scenarios for 3D printed devices with examples and tips...Read More
FDA Extends Remote Inspection of Non-Critical Facilities
FDA has increasingly relied on remote inspections of manufacturing facilities since March 2020. It announced resumption of the normal on-site inspections a few times since then and then re-paused on-site inspections due to the pandemic. Earlier this year, FDA had announced a similar pause in on-site inspections...Read More
FDA Provides Suggestions for Point-of-Care 3D Printing of Devices
Several 3D printed devices may be printed at the clinic rather than printed at a traditional manufacturing facility and shipped. But 3D printing operations still need to comply with FDA’s QSR and GMP requirements. FDA released a Discussion Paper listing three scenarios for 3D printed devices with examples and tips...Read More
FDA Extends Remote Inspection of Non-Critical Facilities
FDA has increasingly relied on remote inspections of manufacturing facilities since March 2020. It announced resumption of the normal on-site inspections a few times since then and then re-paused on-site inspections due to the pandemic. Earlier this year, FDA had announced a similar pause in on-site inspections...Read More
