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Compliance Activities: Quality Starts From Within Through Continuous Improvement (OC Logo)

Procedural Letters
See Related
Manufacturers and Assemblers of Diagnostic X-ray Components and Systems re: Manufacturers’ Information Disclosure Obligations under Title 21CFR1020.30(g) 10/16/2003 Text  
Medical Claims on Labeling and Promotional Materials of Infant Mattresses and Infant Positioners 03/13/2000 Text PDF
Variance for IVD's - Approval of an Alternative Requirement of the User Labeling Requirements for Devices that Contain Dry Natural Rubber 09/10/1999 Text PDF
Likelihood of Facilities Inspections When Modifying Devices Subject to PMA Approval 08/13/1999 Text PDF
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects 03/19/1999   PDF
Letter to Manufacturers of Medical Devices used for In Vitro Fertilization (IVF) and other Assisted Reproduction Procedures 02/19/1999 Text  
Documentation Required for Preamendment Status 12/24/1997 Text  

Updated 10/16/2002

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