FDA Creates Online Device Complaint Reporting Process

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By Dana A. Elfin

Oct. 26 — A new FDA Web page could make it easier for the public to submit complaints about possible regulatory misconduct related to medical devices.

The Food and Drug Administration says the redesigned reporting channel aims to simplify the process for filing device-related complaints, but one regulatory lawyer warns the revamped gateway could increase the number of unfounded 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 have adequate staff to review an increased number of complaints but may lack the resources to investigate them. Gunawardhana formerly worked at the FDA.

FDA Will Monitor Impact

Stephanie Caccomo, a press officer with the FDA, told Bloomberg BNA Oct. 25 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 Web page “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.

Complaints Aren’t New

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 doesn’t think the public was discouraged from filing allegations in the past, Caccomo said, but it “expects the public will find the online submission process ... easier to use,” she said.

“The FDA has always taken emails and calls in regard to allegations,” Gunawardhana said.

Gunawardhana said most of the complaints the FDA receives are made by device company employees or by patients who allege they were harmed rather than by companies.

For his part, Levine said, he was “surprised to see” the FDA’s new online process. “I didn’t think FDA was facing a shortage of complaints from the public alleging regulatory violations by manufacturers.”

Meanwhile, Levine said, “FDA also has announced no improvement in its unsatisfying and untimely process for informing submitters of the outcome of their complaints, telling them to wait six months and submit a FOIA [Freedom of Information Act] request.”

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

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

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