Federal Register #FDA-2026-N-8482

FDA seeks public comment on information collection for regulatory misconduct allegations submitted to CDRH

This opportunity involves the Food and Drug Administration (FDA), under the Department of Health and Human Services, seeking public input on its information collection process for allegations of regulatory misconduct submitted to the Center for Devices and Radiological Health (CDRH). - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Center for Devices and Radiological Health (CDRH) - OEMs and Vendors: - No specific OEMs or vendors are mentioned; the notice is open to the public for voluntary submissions - Products/Services Requested: - Voluntary electronic submissions of allegations regarding regulatory misconduct by medical device manufacturers or marketers - Estimated annual quantity: 2,800 submissions - Average burden: 15 minutes per response - Unique or Notable Requirements: - Submissions are voluntary and may include supporting information and contact details - The information collected is intended to help FDA identify potential risks to patients and determine if further investigation or corrective actions are needed - No specific product or service requirements beyond the voluntary submission of allegations

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to allegations of regulatory misconduct voluntarily submitted to the Center for Devices and Radiological Health (CDRH). This collection supports the voluntary submission of claims that medical device manufacturers or marketers may be violating laws. The information helps FDA identify potential risks to patients and determine if further investigation or corrective steps are needed. Comments must be submitted by October 26, 2026.

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