Search Results for keywords:"FDA"

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Search Results: keywords:"FDA"

  • Type:Notice
    Citation:86 FR 4088
    Reading Time:about 21 minutes

    The Department of Health and Human Services and the Food and Drug Administration (FDA) are proposing to permanently waive certain premarket notification requirements for specific medical devices. This action follows temporary waivers provided during the COVID-19 pandemic to make medical devices more accessible. The proposal includes making seven class I devices and 84 class II devices permanently exempt from the 510(k) premarket notification requirement, which typically involves a costly and time-consuming process. The public is invited to comment on the proposed exemptions and suggest improvements to the regulatory system concerning medical devices.

    Simple Explanation

    The FDA says they want to make it easier and faster for certain medical gadgets to be available by skipping a long check-up process they usually do. They want to hear what people think about this idea and how they could make the process even better.

  • Type:Rule
    Citation:86 FR 462
    Reading Time:about 9 minutes

    The Food and Drug Administration (FDA) has set January 1, 2024, as the uniform compliance date for food labeling regulations that were published between January 1, 2021, and December 31, 2022. This means any new food labeling rules released during this timeframe must be followed by the start of 2024 to reduce the economic impact of labeling changes on the food industry. The FDA states that while these regulations don't immediately introduce new costs, they allow businesses time to adjust their labeling practices. The rule also specifies that special circumstances may justify a different compliance date, which will be detailed as needed.

    Simple Explanation

    The FDA has decided that all new food labels made between 2021 and 2022 need to be ready by January 1, 2024, so companies have enough time to update their packaging and keep things simple and fair.

  • Type:Proposed Rule
    Citation:90 FR 5032
    Reading Time:about 9 hours

    The Food and Drug Administration (FDA) is proposing a new rule to set a maximum nicotine level in cigarettes and other combusted tobacco products. This measure aims to decrease the addictiveness of these products, making it easier for people who want to quit to do so, and to prevent youth from becoming addicted. The rule is expected to benefit public health by reducing the number of individuals who start smoking or continue smoking over time. The proposal could potentially improve health outcomes by reducing the overall harmful effects of tobacco addiction.

    Simple Explanation

    The FDA wants to make cigarettes and similar products have less nicotine, which is the stuff that makes people get hooked, so it's easier for people to stop using them and to help kids not start in the first place.