FDA Device Center Gears Up For Product Reclassification Push

Full article reprinted from "The Gray Sheet" - April 27, 2009

Find out how FDA is hiring additional staff and channeling user fee funds toward device reclassification efforts now that it has committed itself to more rapidly addressing the subset of Class III devices that still enters the market via 510(k).

FDA Device Center Gears Up For Product Reclassification Push

Full article reprinted from "The Gray Sheet" - April 27, 2009

"FDA acknowledges the task remains incomplete and is committing all necessary resources to completing this job," said Kate Cook, CDRH associate director for regulations and policy, at the April 22-23 Food and Drug Law Institute annual conference in Washington, D.C.

"We have more resources now," Cook said. "We are hoping to be able to devote more resources to reclassification of devices in the coming years."

Pre-'76 Devices May Be Class II Candidates - FDA

On April 8, FDA ordered makers of 25 types of devices to submit safety and effectiveness data by Aug. 7 (¹"The Gray Sheet" April 13, 2009, p. 3). The targeted categories were marketed prior to the 1976 Medical Device Amendments and grandfathered into the highest-risk Class III category.

The amendments required FDA to down-classify or solicit PMAs for all pre-amendment devices, but three decades later, the 25 device types, including intra-aortic balloon systems, implantable pacemaker pulse generators, automated external defibrillators and some pedicle screw spinal systems, remain unaddressed. New devices that show substantial equivalence to already-marketed products in these categories enter the market via the 510(k) process.

Critics contend that some potentially unsafe devices have entered the market without sufficient scrutiny as a result of FDA's delay, and the Government Accountability Office in January urged FDA to "take immediate steps" to tackle the last of the pre-amendment devices.

"I'll admit it: it's taken a long time," Cook said. "But at this point, we're moving ahead. This is going to happen."

According to Cook, FDA identified and addressed the riskiest of the pre-amendment devices early on after the 1976 device regulations were enacted, requiring PMAs for contraceptive intra-uterine devices, replacement heart valves and silicone gel-filled breast implants, for example.

As for the remaining product types, many are good candidates for reclassification, while others may have fallen into disuse, Cook said.

"Device types that are still in use have a long marketing history," she noted.

After addressing these device types, FDA will turn its attention back to petitions from third parties requesting reclassifications (typically seeking 510(k), Class II status for PMA products). Petitions can languish at the center for years, CDRH Director Dan Schultz has acknowledged, but he and his staff have committed to speeding up that process (²"The Gray Sheet" June 16, 2008, p. 3).

Debate Continues Over 510(k)s For Implantables

The pre-amendments issue aside, the 510(k) program is otherwise sound, FDA and industry experts at the meeting stressed.

"This is not a rubber stamp or a fast-track approval," Cook stressed.

"The reality is, I think that CDRH asks sometimes too much of us in demonstrating that we are basically the same as a product on the market," device industry attorney and former FDA chief council Stephen Terman added.

Class II status is reserved for products with which FDA is very familiar, Cook said - which may include some implantable or life-sustaining devices.

Critics of the program, such as Diana Zuckerman, president of the National Research Center for Women & Families, disagree about where FDA draws the line between Class II and III.

"How ethical is it to use an implant that hasn't been tested in humans or animals?" Zuckerman argued during an April 23 panel discussion. "The same small changes ... that can make a product better also have the potential to make it more dangerous."

But according to Cook, if FDA puts an implant into Class II, it means "we know a lot about the device; we know a lot about the history of the device; we know the mechanism of action."

If the device differs somewhat from its legally marketed predicate, "the reviewers can hone in on what's different about it, what risks are presented by those changes and actually focus the review on those risks."

Cook emphasized, "A blanket position that clinical data needs to be submitted for all implants is not necessarily sustainable."

CDRH meanwhile is facing internal tension between branch reviewers and supervisors, whose take on 510(k) "substantial equivalence" requirements is sometimes at odds (³"The Gray Sheet" March 16, 2009, p. 3).

"We are committed to getting this right: to getting science right, to getting reviews right," Cook told meeting attendees. "The focus within CDRH, within the whole agency, is going to be trying to make the right decisions and really listening to people when they have differences."

Classification As Congress Intended It?

Ultimately, FDA's reclassification efforts will bring it one step closer to realizing the risk-based, three-tiered classification system that Congress originally intended, Goodwin Proctor partner Mark Heller says.

Risks associated with Class II products are to be mitigated with special controls, such as labeling requirements, performance standards or post-market surveillance, the law dictates.

"The real concern with the 510(k) process is its use as a surrogate for PMAs and performance standards, or, now, special controls," said Heller, who spent nearly a decade in the FDA general counsel's office.

The new wave of reclassifications will presumably be paired with special controls guidance documents, which could address safety concerns. FDA could also revisit higher-risk existing Class II devices and consider imposing additional special controls or performance standards, Heller added.

"Once you have the regulatory controls for class II in place and working, and class III being regulated as originally intended, then 510(k) as written will be a classification provision only," he said.

- Jessica Bylander

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