Dozens, and possibly hundreds, of Class III medical devices don’t need to be in that most stringently regulated category, says Leroy Hamilton, a former CDRH engineer. Further, he says, companies should be able to petition FDA to get relief. Hamilton himself has submitted a petition he says the agency has been trying to ignore for seven months. 

In the petition, he argues for a difficult-to-grasp reading of the 1976 Medical Device Amendments’ definition of Class III medical devices. The petition says there are devices for which there is insufficient information to declare them life-sustaining or life-supporting, of substantial importance in preventing impairment of human health, or presenting a potential unreasonable risk of illness or injury. These devices, Hamilton says, should be exempt from Class III, and yet some devices are being shuffled through that system.

At issue is Form FDA 3429, which Hamilton asserts has been rendered useless for its intended purpose, which is to help staffers and industry decide which class a particular device should fall under. Here is where the story gets a little muddy: Form 3429 is a yes-or-no checklist that CDRH asks submitters to fill out to determine the class of a device, something akin to choose-your-own-adventure books. The form has five questions. However, CDRH checks the first three questions and then uses those answers to determine whether to check the two additional questions, which determine the safety and effectiveness of a device. The “logic flaw,” according to Hamilton, is that after the first three questions, CDRH has already determined whether the device should be Class III, but the final two questions are supposed to be the ones that determine the device classification status. 

Now CDRH is saying that it never really used the form to determine product class and that it relies instead on other data. However, under the radar, the center changed how it reviews the form, assessing all five questions equally. 

Hamilton says he has discussed this with numerous CDRH officials, who will no longer respond to him about the matter. “I’m a purist and an idealist,” Hamilton say. “I know I sound like an obsessed nut, but I’m driven to it [by CDRH officials].”

Hamilton has also been talking about Form FDA 3429 with Washington device lawyers, most of whom disagree with FDA’s interpretation. One who doesn’t is Larry R. Pilot, a former FDA device compliance director who helped write the 1976 law and is well known for faulting many of CDRH’s interpretations of the law and its implementation.

A self-confessed “loose cannon,” Hamilton is so convinced of his stance that he has created his own Web site, www.loosecannon.name/files/Misclassified.html, to help manufacturers avoid Class III designation. Loose cannons, he says, don’t fit well in FDA’s narrow bureaucratic channels.

After presenting Form FDA 3429’s first three Class III–determining yes-or-no questions, Hamilton’s Web site contends that if all three answers are “an unequivocal ‘No,’” the device has been probably been misclassified. There is a possibility that FDA will reclassify the device, but the site contends that a device firm would have to prepare for battle with the agency to make the change.

FDA, the site says, has used the form for decades, making Hamilton “certain that devices were misclassified into Class III because of the logical flaw that has existed in the classification questionnaire for many years.”

The site advises device makers to consider filing a petition to reclassify their devices if they do not satisfy the definition of Class III and have been categorized as such.

“If you believe your device was misclassified into Class III and you think it would be to your advantage to get it reclassified into Class II or even Class I, consult your legal advisor,” Hamilton says. “You should be able to submit a petition to reclassify the device.”

This change also speaks to a larger and continuing problem in CDRH and in almost all federal workplaces since September 11, 2011. Cloistered behind physical and electronic barriers, officials have grown comfortable with isolation and the luxury of making their own procedural and communicational rules. The answers to Form 3429, for example, seem to be the private property of FDA processors. The net effect is that the agency only answers to whom they choose. 

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