21 CFR 866, Subpart G - Tumor Associated Antigen immunological Test Systems
- § 866.6010 — Tumor-associated antigen immunological test system.
- § 866.6020 — Immunomagnetic circulating cancer cell selection and enumeration system.
- § 866.6030 — AFP-L3% immunological test system.
- § 866.6040 — Gene expression profiling test system for breast cancer prognosis.
- § 866.6050 — Ovarian adnexal mass assessment score test system.
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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-7757 RIN Docket No. FDA-2012-N-0165 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective April 9, 2012. 21 CFR Part 866 In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.
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.
§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 360j - General provisions respecting control of devices intended for human use
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 866 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-7757 RIN Docket No. FDA-2012-N-0165 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective April 9, 2012. 21 CFR Part 866 In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.