🏥FDA Notice on Humanitarian Use Devices Information Collection
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices
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 collection related to humanitarian use devices (HUDs) and humanitarian device exemption (HDE).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The text involves compliance and regulatory requirements for businesses related to the collection of information on humanitarian use devices (HUDs). These requirements will impact medical device manufacturers seeking exemptions and approvals, thus affecting their operational and financial strategies.