3 Jul 2025

🏥FDA's Proposed Collection of Information on Device Appeals Process

Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes

Summary

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collections associated with the Center for Devices and Radiological Health Appeals Processes.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$ - Med

The regulatory notice outlines a proposed collection of information from businesses regarding FDA appeals processes. Business owners in the medical device sector must comply with these requirements and provide feedback, impacting operational and compliance practices.

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