FDA’s New Online Device Complaint Process Could Overwhelm Agency


FDA regulatory attorneys say the FDA’s new online reporting channel for the public to submit complaints about possible regulatory misconduct related to medical devices could overwhelm the agency with complaints.

“With this website, FDA may find itself flooded with low quality, unsubstantiated allegations that will create an unproductive distraction for the agency and device manufacturers,” Gregory H. Levine of Ropes & Gray LLP, Washington, told Bloomberg BNA Oct. 25.

Sonali Gunawardhana, an attorney with Wiley Rein in Washington, said the new system could result in more complaints being filed by disgruntled employees as well as more complaints whose allegations can’t be verified. She said the agency may lack the resources to investigate the additional complaints. Gunawardhana formerly worked at the FDA.

The Food and Drug Administration says it will keep an eye on the new reporting portal’s impact. Stephanie Caccomo, a press officer with the FDA, told Bloomberg the agency intends to keep an eye on the complaint numbers. “The FDA will monitor how the online submission process impacts the number of allegations of regulatory misconduct filed,” she said.

Caccomo said the agency developed the website “to provide the public with more information on reporting allegations of regulatory misconduct related to medical devices and provide clear instructions for reporting to the FDA.”

The website explains the process for submitting allegations to the FDA’s Center for Devices and Radiological Health (CDRH) and includes a new online form to simplify the submission process, she said. Caccomo said the FDA “expects the public will find the online submission process ... easier to use,” she said.

Although the agency’s online public reporting portal is new, the FDA has always received these types of complaints in the device area. “The FDA has always taken emails and calls in regard to allegations,” Gunawardhana said.

The new FDA website is at http://src.bna.com/jBH.

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