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Other FDA Documents:

January 6, 2009
Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, December 5, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary, Slides
January 5, 2009
510(k) Final Decisions - December 2008
December 24, 2008
Class I Medical Device Recall: Stryker Leibinger USA., Stryker Custom Cranial Implant Kits
See All FDA Other Releases
 
 

Federal Register Notices:

January 6, 2009
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability
January 9, 2009
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA; Availability
January 9, 2009
Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Enterovirus Nucleic Acid Assay
See All FDA Federal Register Notices
 
 

Guidance Documents:

January 6, 2009
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide
January 2, 2009
Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices
January 2, 2009
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA
See All FDA Guidance Documents
 
 

FDA Articles

2008: High and Low Notes for FDA Enforcers, Budgeteers
(MD&DI)

CDRH Weaves ‘Tangled Web' on LASIK
(MD&DI)

Senators Pick Up Preemption Rollback
(MD&DI)

Does FDA Know Its Litigation Expenses?
(MD&DI)

CDRH Changes Course on Dental Mercury
(MD&DI)

An Honest Assessment May Boost FDA Appropriation
(MD&DI)

Republicans Press FDA on Device Appeals
(MD&DI)

Assessing FDA Regulation of Diagnostic Tests and Services
(MD&DI)

 
 

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