Electronic Submissions For Medical Devices
Electronic Submissions For Medical Devices
August 3, 2020
1
min read
FDA Publishes “Review and Update of Device Establishment Inspection Processes and Standards” Guidance
FDA Publishes “Review and Update of Device Establishment Inspection Processes and Standards” Guidance
July 29, 2020
2
min read
Pre-Sub Process Recommendations
Pre-Sub Process Recommendations
July 17, 2020
3
min read
New and Important Distributor Requirements Under EU MDR
New and Important Distributor Requirements Under EU MDR
July 6, 2020
2
min read
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
June 23, 2020
3
min read
New Unique Device Identifier Deadline Approaches
New Unique Device Identifier Deadline Approaches
May 12, 2020
2
min read
New FDA Guidelines Affect Labeling Consideration for Intravascular Devices with Lubricious Coatings
New FDA Guidelines Affect Labeling Consideration for Intravascular Devices with Lubricious Coatings
May 6, 2020
2
min read
Virtual Audit Planning
Virtual Audit Planning
April 10, 2020
2
min read
FDA Refuse-to-Accept (RTA) Guidance
FDA Refuse-to-Accept (RTA) Guidance
April 5, 2020
2
min read