Department of Health and Human Services December 17, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Manufacturing Site Change Supplements: Content and Submission; 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 ``Manufacturing Site Change Supplements: Content and Submissions; Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.
Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.'' This draft guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray systems and their major components. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of ``electronic products,'' as defined in FDA regulations. This draft guidance, when finalized, will supersede FDA's guidance entitled ``Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment.'' This draft guidance is not final nor is it in effect at this time.
Submission for OMB Review; Annual Survey of Refugees (OMB #0907-0033)
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks to continue data collection for the Annual Survey of Refugees with minor updates to improve survey administration procedures. The Annual Survey of Refugees is a yearly sample survey of refugees entering the U.S. in the previous five fiscal years. No changes to the survey instrument or estimated response burden are proposed.
Listing of Color Additives Subject to Certification; D&C Yellow No. 8; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of October 26, 2018, for the final rule that appeared in the Federal Register of September 25, 2018, and that amended the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.
Medicare and Medicaid Programs, and Other Program Initiatives, and Priorities; Request for Nominations to the Advisory Panel on Outreach and Education (APOE)
This notice requests nominations for individuals to serve on the Advisory Panel on Outreach and Education (APOE).
Meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry
The Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) has scheduled a public meeting. Information about ACTPCMD and the agenda for this meeting can be found on the ACTPCMD website at: https://www.hrsa.gov/advisory-committees/ primarycare-dentist/.
Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.
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