Curiouser and Curiouser… Petitioner on Class III Devices Gets an Answer from FDA

When I was writing last month’s column about former CDRH engineer Leroy Hamilton’s down-the-rabbit-hole quest for a better Form FDA-3429 for guiding device classifications at CDRH, I had no way of knowing that I’d be writing a sequel 30 days later. Such quests for internal self-correction within the agency have been known to take years and yield little in the way of results.
 

Yet lo and behold, early in March, after a rare 20-minute telephone conference call with CDRH director Jeffrey Shuren and deputy director for policy Nancy Stade,  Hamilton received an answer to his petition (it was less than eight months old). The response granted the petition and informed Hamilton that the errant form had already been changed to conform with the law even before his petition had been received.

This is where, with the benefit of an odd mixture of hindsight and new information contained in CDRH’s March 4 petition response, Hamilton’s quest takes on strange, even byzantine aspects reminiscent of the children’s classic, Alice in Wonderland.
 

According to the convoluted four-page response letter signed by Stade, the agency made changes to the form because it “did not account for devices that are not for use in supporting or sustaining human life, are not for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, but are devices for which insufficient information exists to determine that general controls are sufficient to provide a reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance.”
 

More simply put but not openly stated, the form steered devices into Class III if there was insufficient information to determine whether the device should be regulated that way or not. The lay conclusion is that any device that did not have sufficient information to make a determination as to which category the device belonged in was almost automatically categorized into Class III, FDA’s most stringently regulated category. The conclusion is troubling in that FDA’s stated mission (for determining device effectiveness, at least) is to promote a “least burdensome approach,” and yet here is evidence that for decades FDA opted to route products in the “most burdensome” way possible.
 

Another curiousity is that four days before Stade signed that letter, Hamilton sent her an e-mail containing a list of 17 Class III devices he found on FDA’s Web site that he contended obviously did not belong in Class III (see sidebar). These devices included a device for needle destruction, a noninvasive bone growth stimulator, and a medical image analyzer.
 

Stade’s response letter was likely crafted before she received this e-mail (FDA bureaucratic processes are so “stale and moss-covered”—to misquote Rand Paul—that four days isn’t nearly enough time to include a reaction to such a list in a letter responding to an eight-month-old petition on the same topic). Nevertheless, her letter did manage to obliquely assert, in response to a related but unspecific question in Hamilton’s petition, that FDA “is aware of no devices that have been misclassified into Class III as the result of Form FDA 3429.” His petition contained insufficient information to support his claim that certain devices had been misclassified, she wrote.
 

In an attempt to penetrate the rabbit-hole a little more on this point, I e-mailed Stade to ask her explanation for the 17 allegedly misclassified Class III devices. A response came via FDA’s press office, stating that the defective Form FDA 3429 was not used to classify any of them.
 

When I shared this information with Hamilton, he was at first incredulous. In his many attempts over more than eight months to get precisely this information from various people in CDRH, none had come forward with it. Indeed, they shunned his questions.
 

Stade’s disclosure to me raised the question in both our minds: How did the 17 devices get into Class III if not by the questionnaire? Indeed, what use is the questionnaire at all if it plays no part in classifying devices?
 

On first impression, none of the 17 devices (and Hamilton emphasizes there may be more devices that he did not discover) seem to meet the statutory definitions of a Class III device, in that they are not life-supporting or life-sustaining, they are not for a use which is of substantial importance in preventing impairment of human health, and they do not present a potential unreasonable risk of illness or injury.
 

In an e-mail to CDRH ombudsman David Buckles, Hamilton asked for a personal meeting, which he said should take no more than 15 minutes to explain his position that an unknown number of devices, but probably less than 20, have been misclassified into Class III. He wrote to the ombudsman that the situation “has produced or will produce unfortunate consequences for the makers of the affected types of devices and for the FDA as well.” Calling the process well intentioned but misguided, Hamilton noted in the letter “the American people have been deprived or will be deprived of the right to use some safe and effective devices.”
 

Buckles responded saying he had no role to play in the issues Hamilton raised and explained he had several communications with center higher-ups like Shuren and Stade.
 

Hamilton is figuring out his next moves. He told me he feels the experience is leading him to “better understand the beast of White Oak and how to perhaps rein it in.” He says the agency is nameless and faceless, and that understanding who is involved in agency decisions is difficult.
 

“Even during the ’70s it bothered me that missives stated ‘the FDA believes’ when in fact it was a handful of people who believed a particular thing,” Hamilton says. “It gripes me when I see how they distort the truth, twisting the facts to suit their purposes. I’m sure ‘the ends justifies the means’ plays a big role.”
 

Hamilton began gathering material for a book on CDRH behavior after he left in 1976 to work for private industry at the Health Industry Manufacturers Association (now AdvaMed) and as a consultant. “By 1983, I had filled three large binders with proposed and final regulations, and had a pretty good working knowledge of the law.”
 

Completing his book may not be his next step, but he told me he’s not going to drop the misclassification issue.

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