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Our FDA Zone serves as an all-encompassing survey of government and regulatory information. We've compiled FDA- and CDRH-related news, articles, links, and database searches. Best of all, the FDA Zone is updated daily! So check it out, let us know what you think, and stop by our other Resource Centers.
 
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FDA Articles
Ignoring an Inconvenient Truth
FDA’s annual report of significant legal decisions seems to be incomplete without a mention of Utah Medical.
Do FDA Chiefs Have Real Power?
A recently filed lawsuit raises the issue of executive accountability at the agency.
Other FDA Documents:
Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Transcripts
 May 13, 2008
PMA Final Decisions for April 2008
 May 8, 2008
510(k) Final Decisions - April 2008
 May 5, 2008
...see more Other Documents
Federal Register Notices
Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
 May 1, 2008
Federal Register: Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop
 April 30, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing
 April 30, 2008
...see more Federal Register Notices
Guidance Documents
Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization
 May 6, 2008
Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions (Updated 4/24/2008)
 April 24, 2008
Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis
 April 18, 2008
...see more Guidance Documents
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