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 |
|
|
Likelihood of Facilities Inspections When Modifying Devices Subject to
PMA Approval |
08/13/1999 |
|
|
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 |
|
|