Search Results for citation:"86 FR 11298"

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Search Results: citation:"86 FR 11298"

  • Type:Notice
    Citation:86 FR 11298
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) is asking for public feedback on gathering certain data about reprocessed, single-use medical devices under the Paperwork Reduction Act. This public comment period lasts for 60 days, ending on April 26, 2021. The FDA wants to know if the information collection is necessary, how accurate their burden estimates are, and if there are better ways to collect data. This initiative aims to ensure that reprocessed devices clearly show the manufacturer's name or symbol to prevent misbranding, as required by federal law.

    Simple Explanation

    The FDA wants to hear people's thoughts on a plan to make sure that single-use medical gadgets have clear labels showing who made them, so nobody gets confused. They are also interested in knowing if people think collecting this information is important or if there are better ways to do it.