Preambles are the notes that FDA publishes when it announces a proposed or final rule. They respond to comments submitted by industry and the public, and often reveal the intent and FDA's interpretation of the regulation. All preamble files are in PDF format, and require Adobe Acrobat Reader to view.
- 22 April 2010 (77 FR 2010)
The Food and Drug Administration (FDA) is amending procedural regulations that pertain to obtaining, submitting, executing, and filing certain documents to reflect new address information for the Center for Devices and Radiological Health (CDRH). All filings and other documents that are subject to these regulations must be directed to the new addresses. This action is being taken to provide accuracy and clarity to the agency's regulations.
- 8 November 2007 (72 FR 63444)
Proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations
- 9 April 2007 (72 FR 17399)
Corrects the name and contact information for the Division of Small Manufacturers, International and Consumer Assistance.
- 31 March 2006 (71 FR 16228)
Corrects inadvertent typographical errors and other errors.
- 25 May 2004 (69 FR 29829)
Final rule requiring human cell, tissue, and cellular and tissue based product establishments to screen and test cell and tissue donors for risk factors for, and evidence of relevant communicable disease agents and diseases. The QS regulation is amended to clarify the role of the new donor eligibility regulations in relation to the QS regulation.
- 10 March 2004 (69 FR 11313)
Technical amendment which corrects inadvertent typographical errors, and it is intended to improve the accuracy of the agency’s regulations.
- 7 November 2000 (65 FR 66636)
Adds provisions to the scope which address exemptions and variances from device quality system requirements.
- 31 March 2000 (65 FR 17135)
Amends scope by deleting two paragraphs regarding exemptions and variances.
- 30 September 1999 (64 FR 52718)
Proposed new regulations to require manufacturers of human cellular or tissue-based products to screen and test donors of cells and tissues used in those products for risk factors and clinical evidence of relevant communicable disease agents and disease.
- 7 October 1996 (61 FR 52602)
Final Rule Establishing the Quality System Regulation
- July 1995 (Not published in FR)
- Part 1
- Part 2
- Part 3
- Part 4
- Part 5
- Part 6
- Part 7
- Working Draft of the Current Good Manufacturing Practice Final Rule 23 November 1993 (58 FR 61952)
- Part 1
- Part 2
- Proposed changes which would replace quality assurance program requirements with quality system requirements which include design, purchase, and servicing controls; clarify record keeping requirements for device failure and complaint investigations; clarify requirements for qualifying, verifying, and validating processes and specification changes; and clarify requirements for evaluating data and correcting quality problems. Also proposed reorganizing requirements to be more compatible with other international standards.
- November 1990 (Not published in the Federal Register)
Information document which suggested changes to the medical device Good Manufacturing Practices Regulation
- 21 July 1978 (43 FR 31508)
- Original Final Rule
- 1 March 1977 (42 FR 11998)
Original Proposed Rule