FDA Launches Website for Allegations Against Medical Device Manufacturers

Alerts

October 31, 2016

The U.S. Food and Drug Administration (FDA) recently launched a website¹that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.²Misconduct reports were historically submitted electronically (e.g., by email) or by letter. As many reporters wished to maintain anonymity, third parties (e.g., law firms) were often engaged to submit these reports. And once a third-party report was submitted, it was difficult to determine if the FDA commenced an investigation until an enforcement action was made public.

The FDA's new website and simplified reporting form are intended to lower barriers to reporting alleged medical device regulatory violations, to streamline the reporting process, and to provide an avenue to track resulting outcomes.³For example, a report may still be made anonymously⁴by filling out and submitting the FDA's Allegations of Regulatory Misconduct Form. Having a form that can be directly submitted to FDA via the web streamlines the reporting process. Also, as is currently the process, the reporter will receive a letter that acknowledges report submission and provides a tracking number. The tracking number can be used—in conjunction with Freedom of Information Act (FOIA) requests—to determine the outcome of the FDA's investigation resulting from the report. Again, whether the agency actually commences an investigation is not made public

The FDA requests reporters to submit sufficient information to allow the agency to make a detailed investigation of the allegation (including supporting documentation when necessary). Also, only medical device regulatory violation matters qualify for reporting through the FDA's new form. Reports associated with FDA-regulated drugs, biologics, dietary supplements, and cosmetics should be made to other departments of the FDA.⁵

For questions about reporting medical device regulatory violations, dealing with an FDA investigation following a reported violation, or any medical device regulatory matter, please contact David Hoffmeister or any member of the FDA regulatory practice at Wilson Sonsini.

¹"Reporting Allegations of Regulatory Misconduct," FDA (2016); available at: http://www.fda.gov/MedicalDevices/Safety/ReportingAllegationsofRegulatoryMisconduct/default.htm?source=govdelivery&utm_medium=email&utm_ source=govdelivery.

²"Allocations of Regulatory Misconduct Form," FDA (2016); available at: http://www.fda.gov/MedicalDevices/Safety/ReportingAllegationsofRegulatoryMisconduct/ucm526129.htm.

³Reports can be submitted directly using the FDA's web-based form. Alternatively, reports can also be submitted by regular mail and email. In some instances, a report may use more than one submission method (e.g., the report can be made using the FDA’s web-based form, but supporting documents may be emailed).

⁴Anonymity is not absolute. The agency notes that: "The FDA will not share your identity or contact information with anyone outside the FDA unless required to do so by law, regulation, or court order." Also, given that some state actors are known to employ full-time, technically advanced hackers, there is always a de minims possibility that a hacking and subsequent disclosure may remove the vail of anonymity.

⁵Some of these reports may also be submitted online.

Contributors

David M. Hoffmeister