Industrial Engineering & Management

Department of Quality Compliance, Chinook Therapeutics Inc, Seattle, WA 98109, USA

Publications

• Review Article   
  FDA Warning Letters, Consequences and Costs to the US Medical Device Industry
  Author(s): 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. .. Read More»
  DOI: 10.37421/2169-0316.2023.12.216

  Abstract HTML PDF