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US FDA issues notice on preamendment Class III devices


The Food and Drug Administration (FDA) just posted a notice in the April 9, 2009 Federal Register notifying manufacturers of 25 types of Class III medical devices that their products will be subject to scrutiny soon. The 25 products are all "preamendment" Class III devices that were already being sold on the US market prior to 1976. The manufacturers of devices falling into one of those 25 categories will need to submit more information on their safety and effectiveness before August 7, 2009. The result of this is that some products that have been on the market for 30+ years MAY be subject to the rigorous Premarket Approval (PMA) process, or be down classified to Class I or Class II. You can read more about this on our website, which lists all 25 products and provides links to the Federal Register and FDA notices.

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