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FDA requests Hospitals to Volunteer for FDA Site Visits

This letter was sent on April 20, 2001 to the America Hospital Associate and other Hospital groups.

The FDA is seeking volunteers from the hospital community of facilities willing to participate in a site visit program for FDA personnel. This visit will be used to give the FDA a chance to determine how hospitals who perform medical device reprocessing of Class II and III single-use devices are complying with the regulations in order to develop a training course and inspectional guidance for FDA investigators.

The intent of this visit is not regulatory.

If you want more information on this you can contact mdi's offices or visit the FDA website at www.fda.gov/cdrh/reuse/042001_pilot.html

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