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FDA
Items added to the FDA's Center for Devices and Radiological Health website within the last month.
- Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment
- This compliance program provides guidance to FDA field and center staff for the inspection, field test and administrative/enforcement activities related to the Electronic Product Radiation Control (EPRC) provisions of the Federal Food Drug and Cosmetic...
- Thu, 15 May 2008 04:00:00 GMT
- Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Transcripts
- On March 4 and 5, 2008, the committee intends to discuss and make recommendations about computer aided detection and diagnosis (CAD) devices for radiological images, e.g., mammograms, chest x-rays, and computed tomography (CT) images of the lungs or ...
- Tue, 13 May 2008 04:00:00 GMT
- PMA Final Decisions for April 2008
- These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2008.
- Thu, 08 May 2008 04:00:00 GMT
- Summary Information for: Thoratec HeartMate II® Left Ventricular Assist System (LVAS)
- PDF format only. Topics: Ventricular Assist Device
- Wed, 07 May 2008 04:00:00 GMT
- Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization
- This guidance document describes the general administrative procedures FDA will use to categorize tests under CLIA. This guidance does not specifically address CLIA waiver applications.
- Tue, 06 May 2008 04:00:00 GMT
- Worth checking out
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