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FDA Application

Federal Register
Wednesday October 21, 2009

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FDA Federal Register Documents

NOTICES-FINAL GUIDANCES

Docket No. FDA-2009-D-0473, CDRH 200850.  Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems; Availability.  Pages  54055-54056 [FR Doc. E9-25313]  [OFR PUB]

NOTICES-DRAFT GUIDANCES

Docket No. FDA-2009-D-0508, OC 2009293.  Draft Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Availability.  Pages  54052-54053 [FR Doc. E9-25235]  [OFR PUB] Comments on draft guidance by October 30, 2009

Docket No. FDA-2009-D-0503, CDRH 200911.  Draft Guidances for Industry and Food and Drug Administration Staff; Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data--Premarket Notification [510(k)] Submissions and Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data--Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions; Availability (Notice).  Pages  54053-54055 [FR Doc. E9-25233]  [OFR PUB] Comments due January 19, 2010

NOTICES

Docket No. FDA-2009-N-0287, ORA 200912.  Wallace E. Gonsalves, Jr., MD: Debarment Order.  Pages  54051-54052 [FR Doc. E9-25322]  [OFR PUB] Effective date October 21, 2009

FINAL RULES

Docket No. FDA-2009-N-0472, CDRH 200851.  Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Cardiac Allograft Gene Expression Profiling Test System.  Pages  53883-53885 [FR Doc. E9-25315]  [OFR PUB] Effective date November 20, 2009

Table of Contents for Entire Federal Register
Wednesday, October 21, 2009 [Not Available]

 
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