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Medical Devices

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Procedural Letters

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

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