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
FDA Updates Special 510(k) Guidance
FDA Updates Special 510(k) Guidance
March 12, 2020
1
min read