Full article reprinted from "The Gray Sheet" - June 16, 2008
FDA's device chief is putting more pressure on his office to get final device reclassifications out the door, and plans to release several more of them soon.
"We're placing renewed emphasis on reclassifications," CDRH Director Dan Schultz told "The Gray Sheet."
"It's a very difficult, complicated process, but we're trying to make sure that we make it happen within a reasonable period of time. It's not something that can't be done; it just needs a little bit of a push."
Most reclassification requests are for downclassifying products from the highest-risk class III to medium-risk class II category. Petitions can be initiated by individuals, companies, professional groups or by FDA itself.
Reclassification goes much smoother when FDA receives thorough information with the reclassification request, Schultz says. Nonetheless, some products take up to five years to downclassify, and "that's the part that we need to be able to fix."
In the past few weeks, FDA released a flurry of notices related to device reclassifications, including balloon angioplasty catheters and full field digital mammography systems (1"The Gray Sheet" June 2, 2008, p. 5). Schultz and his 510(k) staff say they plan to release others shortly.
"We have a couple more that are in the hopper," Schultz told device industry reps at the 11 annual meeting of FDA and the Orange County Regulatory Affairs group, held June 11-12 in Irvine, Calif.
Some petitions languish at FDA because of resource constraints. But Schultz says he has an improved team and an improved process in place for handling reclassifications "that should make them much more timely than they have been in the past."
"We are actually getting better at it," he said.
Case Study: Absorbable Hemostatic Agents
FDA's ongoing effort to downclassify absorbable hemostatic agents from PMA to 510(k) products meanwhile has generated a some industry pushback.
Absorbable hemostatic agents are devices used to promote coagulation and stop internal bleeding during surgical procedures. They typically consist of a wound dressing and a chemical or biological agent used to control bleeding.
Examples include Johnson & Johnson/Ethicon's Surgifoam absorbable gelatin sponge and absorbable gelatin powder, manufactured by Danish firm Ferrosan, and Surgicel absorbable hemostat.
FDA proposed the reclassification in October 2006 after two advisory panel meetings in 2002 and 2003. The first panel withheld their recommendation until a special controls document was drafted, and the 2003 panel endorsed FDA's proposal (2"The Gray Sheet" July 28, 2003, p. 16).
"For products that have been around as long as these and for as long as the FDA has been collecting adverse events, and [for] how much these products are used, we have very few adverse events that can be attributed to these devices," explained David Krause, a biologist within CDRH's Office of Device Evaluation who drafted the reclassification request and guidance.
"We ought to reclassify."
Ethicon, Ferrosan Vigorously Oppose Reclassification
From the start, Johnson & Johnson/Ethicon, Ferrosan A/S and Integra Lifesciences argued against the reclassification, citing a need for more stringent manufacturing controls.
"They're very serious [products]. If you're going to leave something in the body cavity after surgery, you better know what that product is going to do long-term," Mark DuVal of Minneapolis-based DuVal and Associates, who represents Ferrosan, told "The Gray Sheet." "The products have a lineage of having clinical studies to substantiate the safety and effectiveness of the product."
Continued class III status would also retain high barriers to entry for competitors.
In their comments on the proposed rule, Ethicon and Ferrosan argue that FDA has not been transparent enough in its rulemaking and suggest that the product definition is too broad.
In response, FDA reopened the comment period on the proposed rule until last June to solicit additional feedback (3"The Gray Sheet" May 21, 2007, p. 6).
DuVal filed a citizen petition on behalf of Ferrosan July 2, 2007, asking FDA to refrain from finalizing the reclassification rule and special controls guidance until "an updated and complete" administrative record was made publicly available.
"We couldn't ever figure out what we hadn't put up there," Krause said in an interview. "We put everything we sent the panel up on the Web site. The only thing we could think of later was in my briefing memo to the panel we listed a number of [journal article] references. ... But they were publicly available references."
DuVal requests that the rulemaking be reopened again to allow additional comments based on the full administrative record, and suggests FDA convene another "appropriately composed" advisory panel to review the proposed reclassification.
"We have never opposed reclassification," he said. "We have only asked that the special controls guidance be adequate to assure the safety and effectiveness of these products."
The draft special controls guidance, released in October 2006 along with the original reclassification proposal, "was, in our minds, woefully inadequate," DuVal said.
Krause says the guidance contains "adequate" controls. "We try not to be too prescriptive in our guidance documents. Even though we know a lot about how we want to review these things, somebody might come up with a better idea."
FDA plans to reopen the proposed reclassification rule for additional comments and "once we've seen all the comments and addressed them, then we'll publish the final rule," according to Krause.
With so much back and forth, how the process will conclude is unclear. But FDA's Schultz also confirms that reclassification is on its way. "It is working its way through the process," he says. "I would expect that we will get this thing out within the next few months."
Schultz notes that there have been several reclassifications that have taken even longer than this particular rule. The downclassification of balloon angioplasty catheters, for instance, was requested in 2000, but the agency only decided on the issue late last month.
"I understand there's been a fair amount of frustration in how long it's taken to get these done. It's a very cumbersome administrative process."
- Jessica Bylander
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