The Medical Device Approval Process and Related Legislative Issues Page: 3 of 29
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The Medical Device Approval Process and Related Legislative Issues
Contents
Introduction ..................................................................................................................................... 1
M edical D evices and Their M anufacturers ................................................................................. 3
The History of Law s Governing M edical D evice Regulation.................................................... 4
The Medical Device Approval Process: Premarket Review Requirements.................................. 6
Fundam ental Concepts and Term s of Art............................................................................... 6
Safety and Effectiveness ................................................................................................. 6
Approval and Clearance.................................................................................................. 7
D evice Classification ...................................................................................................... 8
M edical D evice M arketing Applications............................................................................... 9
Before a M arketing Application Is Subm itted ............................................................... 10
Marketing Applications for Medical Devices ....................................................................11
In Vitro Diagnostic Products (IV D ) .............................................................................. 15
The Medical Device Approval Process: Post-Approval Requirements and Issues .................. 18
Labeling ............................................................................................................................ 18
Manufacturing................................................................................................................... 19
Postm arket Surveillance............................................................................................... 19
Com pliance and Enforcem ent...................................................................................... 21
Legislation..................................................................................................................................... 24
IVD Regulation ....................................................................................................................... 24
Liability and Preem ption...................................................................................................... 24
M edicare and Other Federal Coverage............................................................................... 24
Importation.............................................................................................................................. 25
Advertising .............................................................................................................................. 25
Other Issues............................................................................................................................. 25
Tables
Table 1. Funding for the Device Review Process Salaries and Expenses, FY2003-
FY2009......................................................................................................................................... 2
Table 2. M edical D evice Approval Basics.................................................................................... 9
Table 3. CDRH Warning Letters Issued in Total and Under the MQSA, FY2000-FY2008......... 22
Contacts
Author Contact Inform ation ...................................................................................................... 26Congressional Research Service
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The Medical Device Approval Process and Related Legislative Issues, report, January 2, 2009; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc818019/m1/3/: accessed April 25, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.