The National Center for Health Research (NCHR) appreciates the opportunity to submit public comments to the Food and Drug Administration (FDA) regarding their information collection activities concerning allegations of regulatory misconduct voluntarily submitted to the Center for Devices and Radiological Health (CDRH).
NCHR is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
The proposed collection of information is essential to provide CDRH with notice on potential misconduct, so that any such allegations can be efficiently investigated. We agreed that the estimated burden per response is accurate, since for most people this form should take approximately 15 minutes. Of course, the more information that an individual chooses to include, the longer it could take, especially if they plan to choose documents to attach. In addition, to maximize the usefulness of the form in providing usable information, we recommend the following revisions:
1. Clarify which responses are required when submitting the form.
The webpage specifies that the “form does not have to be complete in order for the allegation to be reviewed.” However, it is unclear which responses are required. The asterisks suggest that the “Name and model” and “Detailed description of the allegation…” are likely required. If that is so, the form would be improved by specifically labeling them as such and also requiring a response to the prompt: “Name of the company for which you are submitting an allegation.”
2. Provide the option to submit attachments anonymously.
The FDA notice specifies that respondents can choose to submit a report anonymously. However, that option is impossible if the respondent wishes to submit attachments, since attachments must be submitted in a separate email that inevitably would compromise privacy. To ensure an anonymous option, FDA must enable submissions of attachments on the form.
3. As part of the identification of the product, we suggest adding the option of submitting the web address for the company that makes it, perhaps as an option instead of the address or phone number.