The notice extends an existing information collection
FDA published a Federal Register notice on August 26, 2026, seeking public comment on the continued collection of information for voluntary allegations of regulatory misconduct submitted to the Center for Devices and Radiological Health.
The information collection is identified under OMB Control Number 0910-0769.
This is a Paperwork Reduction Act notice concerning an extension of an existing collection. It does not create a new CDRH enforcement program, a new evidentiary standard, or a new category of prohibited medical-device conduct.
Comments on the proposed information collection are due by October 26, 2026.
The allegation channel covers suspected unlawful conduct
FDA describes a regulatory-misconduct allegation as a claim that a medical-device manufacturer or a person marketing a medical device or CDRH-regulated electronic product may be acting in violation of the law.
Examples in the notice include:
- failure to register an establishment or list a medical device as required;
- marketing an uncleared or unapproved product;
- failure to follow applicable quality system requirements; and
- misleading promotion.
These examples describe the scope of the existing reporting mechanism rather than new violations created by the 2026 notice.
Anyone may submit an allegation
FDA states that anyone may file a complaint reporting alleged regulatory misconduct.
The Agency encourages submitters to provide supporting information and contact information when possible so CDRH can understand the allegation and seek additional information if needed.
Submission does not require the reporter to identify themselves. Allegations may be submitted anonymously, and FDA states that identity or contact information will not be shared outside FDA unless disclosure is required by law, regulation, or court order.
The current channels include the online Allegations of Regulatory Misconduct Form, email, and regular mail.
The collection estimate has increased
FDA now estimates approximately 2,800 electronic submissions per year.
At an estimated 15 minutes per response, the annual reporting burden is approximately 700 hours.
FDA states that this represents an increase of 300 responses and 75 burden hours compared with the prior estimate, attributing the adjustment to an increase in submissions received over the last several years.
The higher estimate indicates increased use of the reporting channel. It does not by itself expand FDA’s enforcement authority.
What medical-device companies can check
- Confirm that U.S. establishment registration, device listing, clearance, and approval status match the products actually being marketed.
- Review websites, distributor materials, social-media claims, and sales content for claims that exceed cleared or approved intended use.
- Make sure internal investigations and document-retention processes can preserve evidence if an external allegation is raised.
- Use complaint and quality-system processes to identify issues that could escalate into a regulatory-misconduct allegation.
- Ensure U.S. compliance teams understand that allegations may be submitted by any person, including anonymously.
For manufacturers, the practical takeaway is not to create a new procedure solely because of this Federal Register notice. The more relevant reminder is that CDRH maintains a low-barrier external reporting channel through which suspected registration, marketing, and quality-system violations can be brought directly to FDA’s attention.
Sources
- Primary official sourceAgency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceAllegations of Regulatory Misconduct Form (opens in a new tab)U.S. Food and Drug Administration