Department of Health and Human Services October 26, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' This guidance document describes a means by which cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify CFTR gene mutation detection systems into class II (special controls). This guidance document is immediately in effect as the special control for CFTR gene mutation detection systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Immunology and Microbiology Devices; Classification of Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection System
The Food and Drug Administration (FDA) is classifying the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection 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: CFTR Gene Mutation Detection 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 announcing the availability of the guidance document that will serve as the special control for the device.
Guidance for Industry on Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This guidance document provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for modified-release dosage forms of potassium chloride.
Supplemental Financial Disclosure Requirements for Employees of the Department of Health and Human Services; Corrections
The Department of Health and Human Services published a final rule in the Federal Register on Wednesday, August 31, 2005 (70 FR 51559), establishing supplemental financial disclosure reporting requirements for certain employees of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). That document contained language that incorrectly rendered the supplemental reporting requirements inapplicable to new entrant employees who file either a public or confidential financial disclosure report. This document corrects the final regulation by revising the appropriate sections.
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