Streamlining Pathways to FDA Medical Device Market Clearance/Approval
03/19/2024
FDA Updates Draft Guidance for Medical Device Submissions: The Q-Submission Program
FDA Updates Draft Guidance for Medical Device Submissions: The Q-Submission Program
FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
Last week, FDA proposed two new rules to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate
FDA’s 2023 device registration renewal period!
FDA recently announced its latest efforts to strengthen and modernize the 510(k) process and to advance the safety and effectiveness of medical devices. As part
How to Avoid and Mitigate U.S. Customs Liquidated Damages and Penalties Did you know that U.S. Customs can assess penalties up to 3x the value
Marketing Sunglasses, Bandages, Hospital Equipment, Pregnancy Test Kits, Cosmetic Devices, Personal Lubricants and More The U.S. leads the world in medical innovation and is the
Protecting Consumers, Limiting Supply Chain Disruption and Avoiding Business and Reputation Damage Quickly and Effectively With product recalls consistently being in the news over undeclared
