Cost of Compliance with Good Manufacturing Practices Regulations by the Medical Device Industry

摘要

This report provides an estimate of the cost to the medical device industry of complying with the Good Manufacturing Practices Regulations. In the absence of baseline data, a sample of 30 plants was visited. Detailed initial and recurring costs were obtained for compliance activities taken in any of ten major categories. The data are presented as detailed case histories so readers can assess what the individual plants did. Projections to the total industry were made based upon number of employees. Several limitations of the methodology are discussed and sensitivity analyses were also performed.