ABSTRACT
Package design and validation have been a concern of the U.S. Food and Drug Administration (FDA) for the past 20 years. At the outset, the medical device amendments to the Food and Drug Act passed in 1976 and the ensuing implementation of a specific set of good manufacturing practice (GMP) requirements of 1978, spelled out the need for packagers of medical devices to design and produce packages that withstand the rigors of sterilization, transportation, and storage.
