Putting PMAs, 510(k)s on a Paper Diet

Originally Published MDDI June 2001 Washington Wrap-up

James G. Dickinson

June 1, 2001

10 Min Read
Putting PMAs, 510(k)s on a Paper Diet

Originally Published MDDI June 2001wash_wrap.jpg

Washington Wrap-up

Putting PMAs, 510(k)s on a Paper Diet

Faced with an ever-increasing workload, CDRH is seeking methods to reduce the bulk of product submissions.

James G. Dickinson

Now into the ninth month of his tenure as CDRH's director of device evaluation, Bernard Statland has ordered a review of his staff's product submission volume. He wants to determine if his reviewers are wading through too much unnecessary information, and thereby slowing decision times.

The former industry CEO and clinical pathologist says that he sometimes sees submissions consisting of as many as 10 volumes of material. His reviewers "feel obligated to read everything that is sent," he says. "If sponsors could send us everything that's relevant in a smaller [package], and better organized, then perhaps we can be more timely. We're just beginning to look at it."

Statland believes that the spirit of FDAMA's "least burdensome" provision, as he understands it, is for FDA to have only the information that is relevant.

Statland does acknowledge that PMA decision times slowed marginally last year, but maintains that the three-year average is at steady-state. As a former industry member, however, Statland says he knows "the burn rate of a dollar when products don't come to market," and he believes there are things he can do to improve review performance.

"If it's a resource problem, I can lobby for more resources. If we're spending too much time on things that are unnecessary, we can develop procedures to decrease that," he says. "Efficiency," Statland emphasizes, "is right up there on the top of my list of priorities."

But Statland also stresses that the goal of increased efficiency is the mutual responsibility of both industry and the agency. "It's not just FDA's review time," he says. "It's really the combination of FDA and the sponsor. If the companies have their submissions presented in a complete manner, easy to read, easy for us to absorb, it will make our job a lot easier."

Statland has spent considerable time speaking on the topic with several groups, including AdvaMed. "I talk about PMA match, which means that the companies and FDA have to match efforts with each other," he says. "[FDA] should let the companies know what it expects, and the companies should hopefully come up with that. It will be a mutual benefit."

"Clinical pathologists"—Statland's former occupation—"are judged on two things: accuracy and turnaround time. So I'm used to that," he adds. "That's the same thing as effectiveness and efficiency."

Statland also believes that the pre-IDE phase is very important. "We need to have the sponsor and ODE agree on what the requirements should be. Then the companies should have a complete submission, so we don't have to send a deficiency letter."

Speaking about the new direction he struck recently in breaking the 20-month deadlock involving the approval of TMJ Implants' Fossa Eminence device (his decision requires labeling to advise patients that there could be nondevice alternatives for their treatment), Statland says product labeling is based on risk sharing.

"We're sharing risk all the time," he says. Statland believes the physician should determine the risk, and tell the patient, "Here's what you'll gain, here's what you possibly could lose," he says. "I don't think anything can be 100% effective, or 100% safe.... Once we let a product go through the approval threshold, then that is risk sharing."

But Statland adds that in order to share risk, the physician must be knowledgeable. "I think it is so important for the physician to read the insert, and it's so very important for the patient to be able to know what could happen."

Just as presenting the optimal PMA submission is the mutual responsibility of the agency and sponsor, Statland says, so too is the broader issue of the device's place in therapy. In a slide presentation he makes to professional and industry meetings, Statland speaks of the shared responsibility of the device maker, the physician, the patient, and FDA.

"The company has the responsibility of making something safe, making it effective, and [providing] full disclosure," he says. "The physician has the responsibility of absorbing what the company comes up with. Then the patient has more and more responsibility for his or her own health."

And Statland adds that the agency has the largest role: "FDA must guarantee that all these things happen; [it] must ultimately evaluate that what has been presented is correct, that [the device] meets the threshold of safety and effectiveness, that the insert is an honest label." When the product hits the marketplace, Statland says, FDA must "monitor [it] to see what happens down the road."

Statland is committed to full disclosure by device manufacturers, he says. Ideally, then, full disclosure becomes the first link in a device information chain linking physicians and patients. Patients, who are becoming more empowered, increasingly come to their physicians armed with pages of information about their problem that they have taken from the Internet. FDA, Statland says, is increasingly playing the role of a catalyst in helping to disseminate objective device information to patients. He cited the agency's Lasik Web page, and suggested that this may be a model for other devices in the future.

Bush Budget Seeks More for FDA

President George W. Bush's first budget request to Congress sought a general 10% increase for FDA (8.5% for the medical device program). It also attempted to reverse a Clinton-era habit of making the agency pay for its staff's cost-of-living salary increases out of the money appropriated for FDA's industry programs. According to agency officials, this means that for the first time in eight years they will be able to avoid program reductions—though they will still be far short of expanding any programs, particularly in the medical device arena.

As part of the Bush budget request, FDA vows to complete first action on 90% of new device applications (PMAs) within 180 days, compared to 74% in 1999.

In support of the administration's budget request for FDA, AdvaMed called on Congress to ensure that FDA has adequate resources to meet its product review timelines.

According to the group, breakthrough devices and combination products (those products considered to be both a device and a drug) have experienced "significant premarket review delays." The group also warned that without adequate funding and resources, "premarket review challenges posed by innovative medical technologies will only increase in the coming years, as FDA faces an ever-increasing number of breakthrough products."

AdvaMed pointed to a recent report that found that medical device and diagnostic manufacturers have doubled their R&D over the past decade. It recommended that "FDA should be given the resources and expertise needed to streamline the entire medical technology development and review process... to begin the process of preparing FDA for a new age of rapid biomedical and pharmaceutical innovation. This new age is rapidly approaching, and the time to start preparing is now."

AdvaMed urged Congress to improve its dialog with FDA to fully understand the total resources needed by the agency to meet its statutory review timeframes. "Such a dialog must also include the resources needed at the Drug and Biologics Centers to review combination device, drug, or biologic products." The group offered its assistance in facilitating and participating in such a dialog.

Inadequate Trending Cited in Warning Letter

An FDA inspection of Kimberly-Clark subsidiary Ballard Medical Products (Draper, UT) revealed significant GMP and quality system regulation deviations, according to a recent agency warning letter. The firm manufactures microCount and microCount Lite liquid scintillation counters, trach care kits, pain management kits, diagnostic test kits, and oral health products.

FDA said its inspection found that the firm's management reviews of its own quality system were not effective. For example, the firm did not have adequate trending procedures and its management review procedure lacked frequency details.

According to the agency, the firm also had inadequate corrective and preventive action procedures and failed to trend customer complaints. In addition, Ballard was found to have been failing to investigate the cause of nonconformities relating to products, processes, and quality systems. FDA said that several complaints involved patient trauma; no medical device reporting submissions were completed, however.

According to the warning letter, the com- pany notified FDA that it has contracted with outside consultants to assist in the correction of the identified problems. FDA told the company that many of its responses to the inspection's FDA-483 were inadequate. It added that certification from the company's outside consultants will be required to ensure that an audit of the firm's facility has confirmed that all corrections have been completed.

FDA Enforcement Actions Profiled

FDA has detailed its major enforcement actions against medical device manufacturers in FY 2000 in its just-released Enforcement Story report.

One case involved an FDA inspection of Delta Medical Center (Memphis, TN). The inspection revealed that the facility failed to submit a medical device report (MDR) after learning that certain devices had malfunctioned and may have caused or contributed to a serious injury. A September 2000 warning letter cited one malfunction of a cardiac pacemaker, one patient injury in July 2000 as a result of a broken belt, and three reports of electric shock from a defibrillator.

In another case, a warning letter was issued in March 2000 to Thoratec Laboratories (Pleasanton, CA). The firm manufactures a ventricular assist device intended for use as a bridge to cardiac transplantation in patients with end-stage heart disease and for postoperative recovery. A January 2000 FDA inspection uncovered significant nonconformance with the quality system and MDR regulations. The list of infractions included the undocumented training of employees who perform activities related to electrical connectors, and a lack of specifications and verification activities for the parting strength of the connectors. "In addition to the QSR violations," the report stated, "Thoratec failed to advise FDA of at least two incidents under the MDR requirements for reportability, as it did not consider the incidents to be serious malfunctions."

To access the full FDA report, visit http://www.fdaweb.com/source/device.htm.

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.

Copyright ©2001 Medical Device & Diagnostic Industry

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