MEDICAL DEVICE HACCP

Hazard Analysis and Critical Control Point (HACCP) is a means of improving the efficiency and effectiveness of medical device inspections.

In 1985 the National Academy of Science recommended that, "The HACCP approach be adopted by all regulatory agencies..." In announcing the Seafood HACCP Regulation, December 18, 1995, former FDA Commissioner Dr. David Kessler stated, "Our safety inspections should focus on preventing problems rather than chasing the horses after they are out of the barn. HACCP is a system that will make that possible."

HACCP principles have proven very successful in food programs administered by both the Food and Drug Administration and the U.S. Department of Agriculture and a national initiative has been underway to provide information and training to the medical device industry regarding HACCP concepts of risk management to identify critical control points, take corrective and preventative actions and greatly reduce inspection time.