The Food and Drug Administration has very straightforward and clear guidelines when it comes to the approval of medical devices. If a medical product is unsafe or ineffective, the FDA can step in and stop the company from continuing to release their defective product.

A New Jersey company was recently barred from continuing with production after the FDA discovered unsafe practices. Accurate Set is a company that was manufacturing a variety of dental products like dental impression materials and repair equipment. After an inspection into quality control practices at Accurate Set, the FDA ordered the company to discontinue operations.

According to reports, the company was negligent in reviewing complaints from customers and correcting defective products. Additionally, they were manufacturing materials and devices that had not been reviewed by the FDA before being put on the market.

The company was in violation of a number of Quality System Regulations that are developed by the FDA. Medical device companies must have procedures in place for handling complaints and assuring the quality of their products. These regulations are designed to keep customers and patients safe. If a product is defective, it is up to the company to respond appropriately.

Accurate Set has since halted operations. If they want to resume their business, they must be reviewed and cleared by the FDA. While a recall has not yet been issued, patients and doctors should be aware of the substandard quality of some of the Accurate Set products. In the event that a person suffers an injury or damage after using a defective product, the manufacturer may be held accountable for any costs associated with their negligence.

Source: ABC News, "FDA Shuts Down New Jersey Dental Products Company," Feb. 13, 2012