What could happen if a device is marketed without FDA approval?

When a device is marketed without FDA approval, one significant consequence is that the manufacturer might face legal action. The FDA regulates medical devices to ensure their safety and effectiveness before they reach the market. If a company chooses to bypass this regulatory process and sells a device without the necessary approval, it can be subject to various legal repercussions. This could include fines, product recalls, and injunctions to stop sales. Furthermore, the company may be held liable for any harm caused by the device if it has not undergone the appropriate evaluations, leading to significant legal and financial ramifications.

Marketing a device without FDA approval could also lead to additional scrutiny and restrictions from health authorities, making it difficult for the manufacturer to sell its products in the future. Therefore, not only does it carry the risk of legal consequences, but it also undermines consumer trust and safety.