Devicemakers Still Leery of Using Third-Party Inspection Program
“We need to get more participation on the part of industry. We haven’t really seen much change yet,” Larry Spears, deputy director for regulatory affairs at CDRH, said at FDAnews’ Fourth Annual FDA Inspections Summit.
The AP program, open to registered domestic and foreign device companies with Class II and III devices, is voluntary and allows manufacturers to have
quality system inspections conducted by approved third parties instead of FDA investigators.
The GMP Letter