Department of Health and Human Services November 5, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes FDA's intention with respect to the enforcement of unique device identification requirements for class I and unclassified devices, other than implantable, life-sustaining, or life-supporting (I/LS/LS) devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements for these devices before September 24, 2022. This guidance also describes FDA's direct mark compliance policy for class III, LS/ LS, and class II devices that are nonsterile, manufactured and labeled prior to their applicable direct mark compliance date, and remain in inventory, as well as for class I and unclassified devices that are nonsterile, manufactured and labeled prior to September 24, 2022, and remain in inventory. FDA does not intend to enforce the direct mark requirements for these devices when the device's unique device identifier (UDI) can be derived from other information directly marked on the device. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Office of the Director, National Institutes of Health (NIH), on behalf of the National Science and Technology Council (NSTC); Committee on Science; Fast Track Action Committee on Health Science and Technology Response to the Opioid Crisis (Opioid FTAC), is requesting input on the content of a draft report, ``Health Research and Development to Stem the Opioid Crisis: A Federal Roadmap.''

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to discuss its efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size- Related Issues, Dual-Column Labeling, and Miscellaneous Topics.'' The draft guidance, when finalized, will provide questions and answers on topics related primarily to implementing two final rules, one entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments,'' and the other entitled ``Food Labeling: Revision of the Nutrition and Supplement Facts Labels.'' This draft guidance also discusses formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and additional issues dealing with compliance.