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Network of Experts- Expert Utilization Standard Operating Procedure (DRAFT)
Purpose The purpose of the Network of Experts is to provide staff at the Center for Devices and Radiological Health (CDRH, Center) with rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise within the Center. This program is designed to broaden the Center for Devices and…
Network of Experts- Expert Enrollment Standard Operating Procedure (DRAFT)
An SOP on the selection and enrollment of organizations for the Center for Devices and Radiological Health (CDRH) Network of Experts. This SOP outlines the criteria and process for selecting scientific, engineering, and clinical organizations for the Network of Experts. The Network and the process for soliciting Network expertise is described more fully in the…
Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health (PDF)
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Information on Denture Adhesives
Background Zinc and Potential Risk Reports of Problems Advice for Denture Wearers Reporting Problems to the FDA Background Denture adhesives are pastes, powders or adhesive pads that may be placed in/on dentures to help them stay in place. Sometimes denture adhesives contain zinc to enhance adhesion. In most cases, properly fitted and maintained dentures should…
Class I Medical Device Recall: Lee Medical International Inc., Custom Dialysis Trays / Kits
Recall Class: Class I Date Recall Initiated: August 15, 2011 Products: Custom Dialysis Trays/Kits (For product names, lot/serial numbers, expiration dates, BIN numbers, please see table below). These products were manufactured from November 17, 2010 through January 11, 2011 and distributed from November 23, 2010 through January 12, 2011. See related Class I Recall Notice…