Industrial Engineering & Management

FDA Warning Letters, Consequences and Costs to the US Medical Device Industry

Abstract

Randy Anderson* and Christabel Tan

To launch or keep a medical device on the US market, FDA pre-approval or continued approval is required. After product approval, the FDA routinely conducts surveillance inspections of medical device companies. The present study looks at issues related to medical device CAPA and the associated costs of remediation for non-compliance with the FDA. This study delves into the costs and issues related to medical device companies for failing to meet FDA expectations. The study will examine the issues that the FDA has with medical device CAPA and suggestions on how to remedy them. This information served as the basis for identifying and examining methods to help reduce or eliminate FDA CAPArelated findings for medical device companies to reduce failure related costs and improving the understanding of CAPA requirements and process efficiencies to help reduce the risk of an FDA finding.

Noncompliance with FDA regulations and failure of medical device quality have resulted in substantial additional costs to a medical device company. Non-routine quality events such as major FDA observations, recalls, warning letters, and consent decrees, along with associated warranties and lawsuits cost the industry between $7.5 billion and $9 billion per year on average. Plus, another $1 billion to $2 billion in lost sales of new and existing products.