FDA Adds Five Additional Unclassified Medical Devices to 510(k) Enforcement Discretion Policy
FDA has updated its guidance on unclassified medical devices, adding five additional device types to its 510(k) enforcement discretion policy. Learn what this means for manufacturers and ongoing FDA compliance obligations.
FDA Launches One-Day Inspectional Assessments Pilot
The FDA has launched a pilot program introducing one-day inspectional assessments across medical products, biologics, clinical research, and food sectors to support more targeted and efficient oversight.