By Jeffrey K. Shapiro –
In our continuing quest to enlighten, we are launching today an occasional series that will examine significant or interesting warning letters involving medical device companies.
As you probably know, FDA issues warning letters to allege violations of the Federal Food, Drug, and Cosmetic Act and/or implementing regulations. A warning letter is a statement of FDA’s enforcement position and a threat to pursue legal remedies if the target does not comply. Usually, the alleged violation does not break new ground. But, on occasion, FDA issues a warning letter that reveals a new or little known enforcement position. This type of warning letter will be our critical focus.
Case in point: A recent warning letter issued by the Philadephia District to a ventilator company appears to create a new standard for reporting malfunctions in life sustaining or life supporting devices or implantable devices.
As background, a malfunction complaint is reportable to FDA if a recurrence would be likely to cause or contribute to a death or serious injury. See 21 C.F.R. § 803.50(a)(2). In this case, there were complaints of ventilator malfunction that were not reported that FDA apparently believes should have been reported. This led FDA to issue a Form 483 observation. The warning letter followed.
The warning letter does not describe the malfunction events at issue. The story gets interesting, however, when FDA assesses the firm’s response to the Form 483 observation. Apparently, the firm had revised its reportability criteria to limit reportability to “ventilator failure modes that result in a loss of therapy.” This limitation seems perfectly reasonable. If a malfunction is not capable of causing a loss of therapy, almost by definition it is unlikely to cause or contribute to a serious injury or death. Therefore, such malfunctions do not trigger the regulatory requirement for reportability.
Yet, FDA rejected the proposed limitation. The agency relies upon the preamble to the medical device adverse event reporting (“MDR”) regulation. See 60 Fed. Reg. 63,578, 63,585 (Dec. 11, 1995) (comment 12). This comment expresses FDA’s interpretive view that a malfunction involving a life sustaining or life supporting device is reportable.
This citation is not adequate to support FDA’s position. 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.)
For 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.
FDA’s final statement in the letter (on this topic) states: “[Y]our firm should submit an MDR for complaints referencing ventilator failures.” This statement introduces a new ambiguity by using the term “failures” rather than “malfunctions.” it appears that FDA is using these terms interchangeably, even though they really are not synonymous. In any event, in light of the warning letter’s earlier rejection of a policy limiting reportability to malfunctions resulting in a loss of therapy, FDA’s position appears to be that all ventilator malfunctions are reportable without further analysis as to whether they meet the reporting criteria in the MDR regulation. If so, FDA’s position extends well beyond the plain language of the MDR regulation.
It is hard to know whether this warning letter is simply a “one off” or a harbinger. Under the previous administration, Chief Counsel’s office was required to review the legal sufficiency and consistency with agency policy of all warning letters. Now that this review is restricted to warning letters that present significant or novel legal issues, it is not clear whether this warning letter received legal review.
What is clear is that the reasoning of this warning letter is not limited to ventilators. It would appear to be applicable to any device deemed life sustaining or life supporting, e.g., insulin infusion pumps, dialysis machines, cardio pulmonary bypass pumps, critical care diagnostic monitors, automated external defibrillators, insulin infusion pumps, and the like. In light of this warning letter, manufacturers of all such devices will need to keep a wary eye on FDA’s enforcement of the MDR regulation.