Title
21 Code of Federal Regulations
· Part
7, Regulatory Practices and Procedures
· Part
11, Electronic Records, Electronic Signatures
· Part
20, Freedom of Information FDA's regulations under the
Freedom of Information Act
· Part
803, Medical Device Reporting
April 2002 edition Part
803, Medical Device Reporting Plain language revision
March 2005
· Part
806, Reports of Corrections and Removals
· Part
807, Establishment Registration and Device Listing
· Part
812, Investigational Device Exemptions
· Part
814, Premarket Approval of Medical Devices
· Federal
Register preamble to the QSR's FDA's response to comments on
the proposed QS regulations
· Part
820, Quality System Regulations Current Good Manufacturing
Practice Regulations
· Part
900, Final Mammography Regulations Effective April 27, 1999
· Part
1000, Electronic Products - General
· Part
1010--Performance Standards For Electronic Products: General
· Part
1020--Performance Standards for Ionizing Radiation Emitting
Products
· Part
1030--Performance Standards for Microwave and Radio Frequency
Emitting Products
· Part
1040--Performance Standards for Light-Emitting Products
· Part
1050--Performance Standards for Sonic, Infrasonic, and
Ultrasonic Radiation-Emitting Products
· FDA
Enforcement Reports
Michael J. Leal, M.S.
Instructor mleal@wpi.edu Last
Modified 1/12/09
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