Department of Health and Human Services August 15, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Announcement of Requirements and Registration for “Lifeline Facebook App Challenge”; Correction
This document corrects a technical error that appeared in the notice published in the August 10, 2011 Federal Register entitled, Announcement of Requirements and Registration for ``Lifeline Facebook App Challenge''.
Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.
Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review.'' The recommendations in this guidance are intended to provide greater clarity on FDA's decisionmaking process with regard to benefit-risk determinations in the premarket review of medical devices. This draft guidance is not final nor is it in effect at this time.
Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in effect at this time.
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