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This article was originally published in The Gray Sheet

Executive Summary

FDA DEVICE CENTER'S EXPEDITED REVIEW DECISIONS WILL REMAIN CONFIDENTIAL until a device is approved for marketing, Susan Alpert, associate director of medical affairs at the agency's office of device evaluation, said at a July 20 Health Industry Manufacturers Association meeting on device submissions in Arlington, Virginia. Alpert stated that "at the time that a device has reached the status [of] approved or is allowed to go to market, we'll make public the fact that the device received expedited review." Retaining confidentiality until device approval responds to industry concerns raised at a June 30 advisory panel chairpersons meeting where FDA unveiled its proposed policy for broadening its expedited review program ("The Gray Sheet" July 5, p. 4). At the advisory panel meeting, the agency said it would publicly disclose decisions to grant expedited review at the time the status was granted. Under the proposal, FDA would have released a generic description of the device, its indications for use, and the central reasons for allowing expedited review. Industry officials, however, complained that such information would violate provisions protecting the confidentiality of pending premarket approval applications and 510(k)s. Addressing the change, Alpert pointed out that FDA "recognized that there were concerns about confidentiality and about the proprietary nature" of submissions, and has "chosen to delay" public communication of a device's expedited status. The proposed expedited review policy expands upon the center's existing policy, which allows fast-track review of devices for "life-threatening or irreversible debilitating conditions with no alternative modalities." Under the revised policy, expedited review also will be considered when an application "offers evidence of a potential for clinically meaningful increased benefit compared to the existing alternatives" or when the device "promises to provide a revolutionary advance (not incremental advantage) over currently available alternative modalities." Asked whether a device would retain its expedited review status if another similar device that entered the agency at about the same time was approved, Alpert indicated that the device might not receive as intensive a review but would retain its place in the review queue. "What we're going to do in that situation is readjust our resources a little bit, perhaps tone down the focus and the intensity of the review, but we are not going to remove the devices that are already in the process...from their place in the queue," she explained. Mark Heller, a partner at Patton, Boggs and Blow in Washington, D.C. and former associate chief counsel for devices in FDA's office of general counsel, expressed concern that the "amount of resources" invested in the device remaining in the queue would be "shifted away." Heller maintained that the process is "not entirely fair" to manufacturers or the public because "if you clear one product through expedition, and you allow other products to come to market more slowly of the same type, what you are doing is increasing price" and decreasing competition. ODE's plans to prioritize review of devices based on risk ("triage") and "refusal to file" initiatives were also discussed at the July 20 meeting (see following story). Addressing triage, Philip Phillips, director of the program operations staff at ODE, estimated that "around 20%" of devices, "at least," will be placed in "Tier I," which provides for the least stringent level of premarket review. The three-tiered triage initiative, or "priority setting and resource allocation" policy, links the level of risk posed by a device to the stringency of review ("The Gray Sheet" March 15, p. 3). "Tier I" review involves "essentially a focused labeling review for the device's intended use/indications for use," while "Tier II" involves "routine scientific labeling review for the majority of 510(k)s and select PMAs," according to FDA's policy document. "Tier III," however, requires an "intensive level of review" and is reserved for first- and second-of-a-kind devices utilizing new technology or having new intended uses, as well as other submissions that require intensive review due to their "inherent risk." Phillips said that FDA "is hoping" to have the triage program, which will be piloted in ODE's division of ophthalmic devices, "up and running in that one division" in the next few weeks. David West, deputy director of ODE, stated that the "triage process is going to take a longer time to fully implement" than the expedited review and "refuse to file" programs, adding that it is unlikely that "you'll see a marked effect of the tier system on the backlog for quite some time." Currently, West explained, ODE's ophthalmic division has "tentatively" drawn up a list of tier assignments that "is being sent to the panel chair of the ophthalmic panel for their input." West said: "We're in the process of having the other divisions go through their devices and make preliminary assignments." He added, however, that it might take "even a month or so" before the classifications are finalized, and that "as far as the assignment of resources according to tiers, that's probably going to take several months." Alpert indicated that the agency's advisory panels will have an active role in the triage program. Noting that the "panel chairs advised us at [the June 30] meeting that they'd like to be continuing participators in our work on assigning our resources according to risk and to be included when those kind of decisions are being made," she said that the device center "will make use of our advisory panels in that capacity."

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