Department of Health and Human Services August 17, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Proposal To Withdraw Approval of MAKENA; Hearing
The Food and Drug Administration (FDA, Agency, or we) has granted a hearing on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL), once weekly), new drug application (NDA) 021945, held by Covis Pharma Group/ Covis Pharma GmbH (Covis). This notice provides information and details regarding the hearing, including the time, date, and format of the hearing, as well as the questions to be posed to the advisory committee at the hearing.
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.'' This guidance is intended to update and provide clarity on the replacement reagent and instrument family policy for manufacturers of in vitro diagnostic devices and FDA staff to promote consistent application of the concepts in this guidance. Specifically, it addresses a manufacturer's application of an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an additional instrument that was previously cleared, or that is a member of an instrument family from which another member has been previously cleared. This document supersedes the final guidance ``Replacement Reagent and Instrument Family Policy'' issued on December 11, 2003.
Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Hydrogen Peroxide- Based Contact Lens Care Products: Consumer Labeling Recommendations Premarket Notification (510(k)) Submissions.'' FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. The labeling recommendations in this draft guidance are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device. This draft guidance is not final nor is it for implementation at this time.
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.'' This guidance document is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,'' issued on November 7, 2013. This final guidance fulfills this FDARA requirement and supersedes ``Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,'' dated February 25, 2009.
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with the new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that will become obsolete as a result of changes to the hearing aid requirements. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.
Senior Executive Service Performance Review Board
HRSA, an operating division of HHS, is publishing a list of individuals who may be named to serve on the Senior Executive Service Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members for the Fiscal Years 2022 and 2023.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
