FDA Improves the Process for Filing Complaints About Medical Device Companies

October 27, 2023By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh

In our June blog post, we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies.  FDA uses this program to help it identify risks and to determine whether further investigation is needed.  Because this program requires information collection from the public, the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501) and its implementing regulations at 5 CFR 1320, requires federal agencies to minimize paperwork burden and ensure quality of information, amongst other objectives. On October 12, 2023, FDA published a notice reporting on several comments about its information collection activities under this program, and the changes FDA made to address those concerns.

One comment FDA received had noted that existing procedures do not allow for complete anonymity, specifically when requiring that attachments be sent via email. While changes have not been made to allow for attachments to the Allegations of Regulatory Misconduct Form, which would address this comment in part, FDA did acknowledge confidentiality as “an important concern” and cited that under the Freedom of Information Act (FOIA) (5 U.S.C. 552), there are exemptions from mandatory disclosure. While we would encourage providing contact information so that FDA may follow up, if need be, we appreciate the value of being able to submit information anonymously.

Another comment questioned FDA’s process to verify the accuracy and validity of the allegations. In response, FDA noted that it reviews allegations of regulatory misconduct and prioritizes taking action based on risk level, but did not address any specifics on how or whether it decides when to follow-up with subsequent questions about an allegation. We renew our comment from June that transparency on FDA’s activities in response to allegations would make the program much more meaningful to industry.

In response to comments on improving the submission form, FDA already has implemented a notable change by adding asterisks on the Allegations of Regulatory Misconduct Form, to identify the fields that are required (e.g. name and model of medical device and detailed description of the allegation with any supporting documentation) versus non-required. This will help streamline the submission for those complaints that may not have all the information to complete the fields. We also note that an assistant director for allegations has now been identified in the CDRH management directory. We hope to be surprised with more changes that result in transparency on the process and progress of all investigations FDA undertakes when reviewing allegations of regulatory misconduct.