| Subject: | FDA Provides List of Reprocessed Single Use Devices No Longer to be Marketed for Use |
| Category: | Food and Drug Administration (FDA)
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| Published: | Mon, 15 Nov 2004 - 10:00 am |
| The FDA has completed a review of supplemental validation data submitted by firms that reprocess medical devices originally intended for single use only (SUDs). The FDA has allowed certain types of previously cleared reprocessed SUDs to be marketed, however supplemental data for cleaning, sterility and functionality had to be submitted to the FDA for review to determine if certain reprocessed SUDs were safe for use. The FDA's review determined that although many reprocessed SUDs can continue to... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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