FDA tells Invisalign Maker to Report Side Effects

  • Date: December 09, 2010
  • Source: Admin
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The FDA has issued a warning letter to Align Technology Inc., a company that makes a popular teeth straightener, the Invisalign system, on its failure to report information about patient side effects. The warning letter accused the company of failing to comply with FDA requirements to report serious side effects associated with medical devices. It cited some patient complaints about allergic reactions to the Invisalign trays such as swollen lips and mouth ulcers.

Align Technology's general counsel, Roger George admitted that the company had received a warning letter from the FDA on Nov 18 following an inspection and that it had replied to the FDA on Nov 22. It is working to resolve the issue.

FDA regulations on medical devices
Medical device compliance activities promote and protect public health by ensuring the safety and effectiveness of medical devices through enforcement of the Federal Food, Drug, and Cosmetic Act. The devices are classified as follows:
  • Class I devices are defined as non-life sustaining. These products are the least complicated and their failure poses little risk.  
  • Class II devices are more complicated and present more risk than Class I devices, though they are also non-life sustaining. They are also subject to any specific performance standards.
  • Class III devices sustain or support life, so their failure is life-threatening.
A medical device can be marketed in USA only after submitting a marketing application to the FDA and receiving its approval. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.

FDA Action
In 2004, FDA sought an injunction against Utah Medical Products, Inc. (Utah Medical), of Midvale, Utah. The government took this action after a series of FDA inspections over three years revealed a pattern of significant deviations from the Quality System regulation at Utah Medical's Midvale facility. Despite repeated warnings from the FDA, including a warning letter following one of the inspections, Utah Medical had consistently failed to ensure that its products were manufactured in accordance with the Quality System regulation. Subsequently the government's complaint was filed by the U.S Department of Justice in the District Court of Utah. Thereafter the manufacture and distribution of medical devices by the company was banned until the firm could demonstrate a correction in the deviations from CGMP (Current Good Manufacturing Practices).


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