Spurred by FDASIA, a 10-page Federal Register Notice seems like an FDA power grab.

April 30, 2013

5 Min Read
Another Classification Kerfuffle at FDA

In the 2012 FDA Safety and Innovation Act enacted last summer, FDA managed to persuade Congress give it new administrative-order authority over the classification of devices that were grandfathered in the pre-1976 Medical Device Amendments. Now, the agency’s effort in replacing notice-and-comment rulemaking with administrative order authority has produced three targets. 


EPI has been unsuccessful getting FDA to downgrade its Alpha-Stim electrotherapy device to Class II. Now FDA may require PMA, based on "not enough" information.

In the first week of April 2013, FDA published an incredibly dense 10-page Federal Register notice, proposing to order the reclassification of three Class III pre-amendments devices to require PMA or notice of completion of product development protocol.

These devices are the sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; the cranial electrotherapy stimulator (CES) for the treatment of depression, anxiety and insomnia; and the transilluminator for breast evaluation.

Only the directly affected companies and their lawyers were able to follow the notice, and then only after multiple readings. Industry stalwart Washington guardians, Advamed, and MDMA said not a word about it.

One of the directly affected companies swiftly expressed concern that for 14 months, CDRH has failed to correct an erroneous official position that its devices present a safety risk.

The company, Mineral Wells, TX-based Electromedical Products International (EPI) has been trying to convince the center that its CES device, Alpha-Stim, does not belong in Class III where the 1976 statute arbitrarily placed it pending future FDA reclassification. The April 4 notice represents FDA’s third attempt since 1993 to assert status for CES devices, each of the prior two being frustrated by company resistance.

Initially, FDA tried to assert on the basis of literature reviews that CES devices had a risk of causing potentially lethal seizures, but at a February 10, 2012 Neurological Devices Panel meeting, industry experts were able to show that the literature had been misinterpreted by FDA. Only two seizures had ever been reported, and these occurred before use of a CES device.

FDA ultimately dropped this justification for keeping CES devices in Class III but continued to insist that not enough was known about the devices’ safety and effectiveness to down-classify them into Class II, as their manufacturers wanted.
“Not enough known,” however, is not among the statutory definitions qualifying a device for Class III and mandating approval of a PMA, but this isn’t stopping FDA from forging ahead.

In its April 4 proposed order, the agency lists four “risks to health” from CES devices:

  • Possible worsening of the condition being treated if the device is not effective.

  • Skin irritation that may be caused.

  • Reported cases of post-treatment headaches.

  • Unknown adverse effects that potentially may occur from electrical stimulation of the brain.

Citing glowing reports from military experience with more than 1200 Alpha-Stim devices since 2005, EPI board chairman, Daniel L. Kirsch told FDA after the proposed order was published that his device does not meet the statutory requirements for Class III.

“The only manner in which FDA might argue that CES devices meet the Class III definition,” Kirsch wrote, “is if it were to assert that CES devices provide an ‘unreasonable risk of illness or injury.’” However, EPI has shown “that CES devices are safe with no unreasonable risk of injury or illness.”

Kirsch cited that from 2007 to 2011 there were approximately 8,200,000 treatments administered using EPI’s Alpha-Stim device. Among these, the only adverse events reported were 11 skin irritation events, two instances of tinnitus, one claim of panic attack, and one case of a patient’s tongue turning black (which was later found to have been due to an over-the-counter medication)—all adding up to an incident rate of .00018%.

Increasing FDA’s administrative authority, especially when done in a way that eliminates a more open process like public notice-and-comment rulemaking, is a troubling concept.

In its deeply obscured essence, the notice represents a power grab by FDA. In one fell swoop, FDASIA replaced notice-and-comment rulemaking. For decades the agency had blamed this process for inhibiting the agency’s ability to complete the required reclassification of all preamendments devices. However, as demonstrated by the CES example, FDASIA also allows FDA to hold hostage in Class III, those devices that might be candidates for down-classification.

A Hyman Phelps & McNamara legal analysis on FDASIA’s passage predicted the possibility of difficulties with recalssification. “CDRH’s perspective is that, as a result, it could now take longer to down-classify certain devices. The industry representative on the panel acknowledged that in urging Congress to require a panel prior to reclassification, industry was concerned about up-classification, and perhaps had not considered the impact on down-classifying devices.” 

Further, the report noted that CDRH “seemed unsure about how the new law will affect the progress made to date on reclassifying some of the Class III devices for which FDA has not yet called for PMAs. CDRH indicated that progress would likely be stalled, and panels would need to be called. It is not clear whether the law was intended to have this type of retroactive effect.”

Jim Dickinson writes the Washington Wrap-Up Column for MD+DI. 

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