Any device malfunction, regardless its severity, is a reportable event under FDA’s Medical Device Reporting regulation for all life-supporting or life-sustaining devices. That is the official word from CDRH’s Office of Surveillance and Biometrics MDR Policy Branch. Malfunctions for other devices are not reportable unless they are likely to result in a death, serious injury or other significant adverse event experience, according to FDA spokeswoman Morgan Liscinsky. A guidance document is also available on the FDA website. that outlines the reporting criteria, she said.

This blanket reporting requirement for all life-supporting and life-sustaining device malfunctions caught the attention of Hyman, Phelps & McNamara attorney Jeffrey Shapiro after reading an October 10 warning letter to Respironics Inc.

Writing in his firm’s blog, Shapiro says the agency uses a preamble comment from its MDR rule to justify its blanket reporting requirement. “This citation is not adequate to support FDA’s position,” he wrote. “In context, the preamble statement seems merely intended to establish an enforcement presumption that loss of therapy in a life sustaining or life supporting device is likely to cause a serious injury or death. The preamble does not appear to intend that literally every possible malfunction in such a device will be reportable even if the basic regulatory requirements for reportability are absent. (Even if that were FDA’s intent, the agency legally cannot alter the basic terms of a regulation via a preamble statement.)”

To illustrate his argument, Shapiro offered the following example: “If a red light bulb in an ‘on’ switch indicator in a ventilator is off because internal wiring has gone bad, but a white bulb next to it still works and the user can tell that the device is ‘on,’ there would be no interruption in treatment due to this malfunction and no death or serious injury could occur. Therefore, this malfunction is not reportable under the MDR regulation. Under the approach taken in FDA’s Warning Letter, however, it would appear that this malfunction would need to be reported.”

Concerning Shapiro’s example, Liscinsky said MDR policy staff recommend that firms seek an MDR reporting exemption for such a scenario.

Shapiro says it is difficult to know if the warning letter is a harbinger, not knowing whether it received a legal review before leaving the Philadelphia District Office. Just to be safe, “manufacturers of all such devices will need to keep a wary eye on FDA’s enforcement of the MDR regulation,” he cautioned.