📦FDA Proposed Info Collection for Medical Device Exports
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval
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 reporting requirements for firms that intend to export certain unapproved medical devices.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text discusses a proposed information collection requirement by the FDA for firms intending to export unapproved medical devices. This regulation creates compliance obligations that can directly affect operational processes and costs for businesses in the medical device industry.