Allegations of Regulatory Misconduct Against Medical Device Manufacturers: Greater Transparency Needed

October 4, 2022By Véronique Li, Senior Medical Device Regulation Expert

Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. Allegations may include failure to register and list a medical device, promotion of a device outside the scope of its clearance or approval, and marketing a device without an appropriate clearance of approval. Reporting these allegations to FDA is important as the Agency may be unaware of the actions of these manufacturers and marketers, thus creating potential risks to patients.

FDA reviews allegations submitted through the Allegation of Regulatory Misconduct Form, by email, or by regular mail to determine whether an investigation and any follow up activity is justified. Although these allegations can be submitted anonymously, FDA encourages the submitter to provide contact information in case additional background is needed. When reporting an allegation of regulatory misconduct, FDA advises on identifying the medical device at issue as well as its model number, serial/lot/part numbers, and the name of the company, its location and telephone.

If contact information is provided, FDA will respond with an acknowledgment from the Allegation of Regulatory Misconduct Team at FDA. This acknowledgment will include an FDA-assigned identification number for the allegation report. The acknowledgment also states that “[w]hile FDA does not provide information on ongoing investigations, information can be obtained through a Freedom of Information Act (FOIA) Request.” FOIA requests can be submitted online. FDA encourages waiting at least 6 months to make such a request for related records; FDA cites this as the average time to complete an investigation. If the request pertains to 510(k)s, PMAs, or De Novos, FOIA requests can “take approximately 18 – 24 months to process.”

Without constant vigilance of the warning letter, inspection, or recall databases, learning the outcome of any regulatory action can be sluggish and inconclusive. We analyzed FOIA logs from the last five years for allegations of regulatory misconduct. While we know who submitted FOIA requests, the subject of these requests, and the control number for each request, the status of these reports is largely listed as “pending action” or altogether absent from FOIA logs for FY 2017 – FY 2021. When reviewing each month’s FOIA logs from September 2018 to August 2022, the status is “closed” or “withdrawn[,] closed w/o [without] charges.” The time in which these requests were completed ranged from months to years. Any specific action as a result of the allegations are not publicly disclosed.

This means there needs to be a better way to understand the outcomes of urgent issues. If the original complainant of the allegations of regulatory misconduct is to wait at least 6 months to submit a FOIA request and then at least another 18 – 24 months for it to process, years will have gone by without any insight on the assessment and resulting actions undertaken by FDA. This is unproductive. We recommend FDA engage with the complainant and keep them abreast of any investigation and subsequent efforts to bring the offending party back in line.

Categories: Medical Devices