FDAs regulations under the Freedom of Information Act

Reports of corrections and removals

Selected sections

Medical Device Reporting Plain language revision March 2005

Part 20

Part 803

Part 806

Michael J. Leal, M.S.

Instructor mleal@wpi.edu Last Modified 1/26/10

Title 21 Code of Federal Regulations

Enforcement Policy Recalls

Part 7

Electronic Records, electronic signatures

Part 11

Establishment registration and listing

Part 807

Investigational device exemptions

Part 812

Premarket approval of medical devices

Part 814

FDA's response to comments on the proposed QS regulations

Federal Register: October 7, 1996 (Volume 61, Number 195)

Quality System Regulations, Current Good Manufacturing Practice Regulations

Part 820

Mammography Quality Standards regulations

Part 900

Electronic products General

Part 1000

Performance standards for electronic products: General

Part 1010

Performance standards for ionizing radiation emitting products

Part 1020

Performance standards for microwave and radio frequency emitting Products

Part 1030

Performance standards for light emitting products

Part 1040

Performance standards for sonic, infrasonic, and ultrasonic radiation-emitting products

Part 1050