The US Food and Drug Administration announced a consent decree with a NJ company to halt the production of an unapproved medical device. Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.
This is perhaps the most common error made by product manufacturers and distributors. The definition of a medical device is intentionally broad and requires careful evaluation prior to the marketing and sale of a product that may be classified as a medical device. The FDA is notably monitoring and shutting down production of unapproved devices (read more).
Under the terms of the consent decree, Accurate Set must discontinue its operations until the FDA clears or approves its products, which include a variety of restorative dental products such as dental impression and repair materials. In addition, any future manufacturing must fully comply with the FDA’s quality standards.
“The FDA has very clear requirements for the clearance, approval, and production of medical devices,” said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.
The FDA’s most recent inspection of Accurate Set, between December 2010 and January 2011, revealed significant violations of the FDA’s Quality System (QS) regulation, including violations related to the firm’s corrective action and consumer complaint procedures, purchasing controls, and quality audits. The QS regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices.
Investigators also found that medical devices made by the company, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA premarket review.
Accurate Set and Adams have represented that they are no longer manufacturing or distributing any devices. If they decide to resume operations, they first must obtain FDA approval or clearance for their medical devices. The consent decree also requires them to comply with the QS regulation for all their devices and to retain an independent expert to inspect their operations and certify to the FDA that the necessary corrections have been made.
“This consent decree demonstrates the FDA’s commitment to protecting the public health from the dangers of unapproved and improperly manufactured medical devices,” said Dara A. Corrigan, associate commissioner for regulatory affairs.
In the event of future violations, the FDA may order Accurate Set and Adams to stop manufacturing and distributing medical devices and to recall those already on the market. The FDA can take other actions to ensure that they comply with FDA regulations, and may require Accurate Set and Adams to pay damages if they fail to satisfy the decree’s provisions.
The consent decree was signed by Judge Susan D. Wigenton of the U.S. District Court for the District of New Jersey on February 7, 2012.
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