Webinar on Failure Analysis, Product Recalls, and Liability: Measures to Help Prevent the FDA From Knocking on Your Door
The current regulatory and litigation environments in the United States require that potential safety issues and product nonconformances of widely-distributed medical devices be vigorously investigated and quickly remedied in order to ensure patient safety. How well a company manages a recall plan or deals with regulatory non-conformity matters, as outlined in a 483 or FDA Warning Letter, can also affect not only the future viability of the product, the company’s liability, and financial loss, but can also affect a company’s good name, reputation, and "brand equity."
Reaching a decision to recall a product, and conducting the recall, requires careful evaluation, including analysis of adverse-event reports, identification of the specific products or lots of products to be recalled, execution of a health hazard evaluation, and implementation of a Corrective and Preventive Action (CAPA) plan, including a root-cause analysis. A firm’s success in interacting with FDA and communicating with health-care professionals, the media, the public, and its own employees can have a major impact on future perceptions of the company and possible liability. In addition, determining whether a device failure occurred, and identifying and correcting its cause, are critical to avoiding government-imposed shut-downs, getting a product back on the market after a recall, and helping to avoid litigation.
Arent Fox LLP
Jorge Ochoa Ph.D., P.E.
Principal Engineer, Biomedical Engineering