Department of Health and Human Services June 20, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.'' The purpose of this document is to outline FDA's proposed recommendations and expectations for the evaluation and reporting of age, race, and ethnicity data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups. This draft guidance is not final nor is it in effect at this time.
Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication
The Food and Drug Administration (FDA) is republishing in its entirety a notice entitled ``Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non- Quantitative) Test System in a Reagent Tablet Format'' that published in the Federal Register on May 4, 2016 (81 FR 26802). FDA is republishing to correct an inadvertent error in the Docket Number and to announce a revised comment period. FDA is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
