21 CFR Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES
- SUBPART A — General Provisions (§§ 864.1 - 864.9)
- SUBPART B — Biological Stains (§§ 864.1850 - 864.1860)
- SUBPART C — Cell And Tissue Culture Products (§§ 864.2220 - 864.2875)
- SUBPART D — Pathology Instrumentation and Accessories (§§ 864.3010 - 864.3875)
- SUBPART E — Specimen Preparation Reagents (§§ 864.4010 - 864.4400)
- SUBPART F — Automated and Semi-Automated Hematology Devices (§§ 864.5200 - 864.5950)
- SUBPART G — Manual Hematology Devices (§§ 864.6100 - 864.6700)
- SUBPART H — Hematology Kits and Packages (§§ 864.7040 - 864.7925)
- SUBPART I — Hematology Reagents (§§ 864.8100 - 864.8950)
- SUBPART J — Products Used In Establishments That Manufacture Blood and Blood Products (§§ 864.9050 - 864.9875)
- SUBPART K — Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (§§ 864.9900 - 864.9900)
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 351 - Adulterated drugs and devices
§ 360 - Registration of producers of drugs or devices
§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 360j - General provisions respecting control of devices intended for human use
§ 371 - Regulations and hearings
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 864 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-06826 RIN Docket No. FDA-2013-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 26, 2013. 21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.