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

Instructor mleal@wpi.edu Last Modified 1/12/09