Department of Health and Human Services March 23, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 24 of 24
Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization Enumeration Systems
The Food and Drug Administration (FDA) is classifying automated fluorescence in situ hybridization (FISH) enumeration systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems.'' This guidance document describes a means by which automated FISH enumeration systems may comply with the requirements of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify automated FISH enumeration systems into class II (special controls). This guidance document is immediately in effect as the special control for automated FISH enumeration systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Substances Affirmed as Generally Recognized as Safe: Menhaden Oil
The Food and Drug Administration (FDA) is amending its regulations by reallocating the uses of menhaden oil in food that currently are established in the regulations, with the condition that when menhaden oil is added to food it is not used in combination with other added oils that are significant sources of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Guidance for Industry on Pharmacogenomic Data Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pharmacogenomic Data Submissions.'' The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug development process, the format of submissions, and how the data will be used in regulatory decisionmaking. The guidance is intended to facilitate scientific progress in the area of pharmacogenomics.
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