Department of Health and Human Services March 15, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling.'' FDA is issuing this draft guidance document to describe relevant information that should be provided in premarket submissions to support the evaluation of thermal effects of medical devices that produce local, regional, and/or systemic changes in tissue temperature (i.e., heating and/or cooling) due to their use. The recommendations in this draft guidance reflect current review practices and are intended to promote consistency and facilitate efficient review of thermal effects data in premarket submissions for these devices. This draft guidance is not final nor is it for implementation at this time.
Determination That NUCYNTA (Tapentadol Hydrochloride) Solution, Equivalent 20 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that NUCYNTA (tapentadol hydrochloride) solution, equivalent (eq) 20 milligrams (mg) base/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tapentadol hydrochloride solution, eq 20 mg base/mL, if all other legal and regulatory requirements are met.
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.'' This draft guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This draft guidance, when finalized, is intended to supersede the document entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program'' issued on June 2, 2023, and provides clarification and additional information on the scope of Q- Submission (Q-Sub) types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre- Submission or other Q-Submission types), and improved examples. This draft guidance is not final nor is it for implementation at this time.
Determination That DUEXIS (Ibuprofen and Famotidine) Tablet, 800 Milligrams and 26.6 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that DUEXIS (ibuprofen and famotidine) tablet, 800 milligrams (mg) ibuprofen and 26.6 mg famotidine, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality
The Food and Drug Administration (FDA or we) is revoking the standard of identity and the standard of quality for frozen cherry pie. This action, in part, responds to a citizen petition submitted by the American Bakers Association (ABA). We conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. Revocation of the standards of identity and quality for frozen cherry pie will provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
Approval Tests and Standards for Combination Unit Respirators
The Department of Health and Human Service (HHS) proposes to amend regulatory requirements that would be used by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) to test and approve combination unit respirators. This rulemaking would establish this new class of respiratory protective device, combination unit respirators (CURs), by incorporating by reference the performance requirements established in the National Fire Protection Association (NFPA) voluntary consensus standard NFPA 1987, Standard on Combination Unit Respirator Systems for Tactical and Technical Operations.
Medical Devices; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to update a citation for information collection and conform the regulatory provisions to the Federal Food, Drug, and Cosmetics Act (FD&C Act). The rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors and to ensure accuracy and clarity in the Agency's regulations.
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