Department of Health and Human Services October 21, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting via teleconference. The meeting is open to the public. Pre-registration is not required, however, individuals who wish to participate in the public comment session should either e-mail nvpo@hhs.gov or call 202- 690-5566 to register and RSVP.
Wallace E. Gonsalves, Jr., MD: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Wallace E. Gonsalves, Jr., MD, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Gonsalves was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Gonsalves failed to request a hearing. Dr. Gonsalves' failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Cardiac Allograft Gene Expression Profiling Test Systems
The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling test 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: Cardiac Allograft Gene Expression Profiling Test Systems.'' FDA classified 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 this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the special controls guidance document entitled ``Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems.'' This guidance document describes a means by which cardiac allograft gene expression profiling test systems may comply with the requirement 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 codifying the classification of cardiac allograft gene expression profiling test systems into class II (special controls), and establishing this guidance document as the special control for this device.
Draft Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' The draft guidance document is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA under The Family Smoking Prevention and Tobacco Control Act (FSPTCA).
Draft Guidances for Industry and Food and Drug Administration Staff; Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data-Premarket Notification [510(k)] Submissions and Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data-Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of two related draft guidance documents. One is a draft guidance entitled, ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Notification [510(k)] Submissions'' (``CADe 510(k) draft guidance''). This draft guidance provides recommendations regarding premarket notification (510(k)) submissions of certain computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The second draft guidance is entitled, ``Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Approval (PMA) and Premarket Notification [510(k)] Submissions'' (``CADe clinical performance assessment draft guidance''). This draft guidance provides recommendations on how to design and conduct clinical performance studies for CADe devices applied to radiology images and radiology device data. These studies may be part of a premarket submission to FDA, whether it is a 510(k) submission, an application for premarket approval (PMA), an application for a humanitarian device exemption (HDE), or an application for an investigational device exemption (IDE). These draft guidances are not final nor are they in effect at this time.
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