FDA Launches New Program for Combination Product Inspections

The FDA has launched a new compliance program for inspections of combination products that include devices.

The program applies to inspections of manufacturers of single-entity and co-packaged finished combination products that include both drug and device or biological product and device constituent parts.

Under the program, manufacturers can demonstrate compliance with current good manufacturing practices (cGMPs) by demonstrating compliance with the specific cGMPs for each component.