Medical Device Daily Washington Editor

WASHINGTON — The question of how tightly devices are scrutinized drives a lot of chatter in policy circles of late, but few in industry would disagree that reviewers at the Center for Devices and Radiological Health are interested in more exhaustive safety data – and indeed, data of all sorts – than in times gone by.

The only question to be answered might have been posed by Goldilocks had she stumbled upon an FDA building rather than the bears' house: How much data is just enough?

Judy Meritz, an attorney and shareholder with the DC office of the law firm of Baker Donaldson moderated an early afternoon session at Wednesday's session of the annual meeting held jointly by FDA and the Food and Drug Law Institute (FDLI; Washington) dealing with device safety and mentioned the extensive coverage of medical devices in the nation's mainstream media, including the New York Times. She remarked, "It's a sign that we as device professionals are not the only ones concerned" about device safety.

Meritz also noted that the April 21 edition of the Times covered a meeting held by the director of the Office of Device Evaluation (ODE), Donna-Bea Tillman, PhD. The article described the session as "an unusual internal meeting," which the author states ODE has not held for two years. However, an FDA official who spoke at the following FDA/FDLI session noted that there was nothing conspicuous inasmuch as Tillman opted last year to hold several smaller meetings rather than an "all-hands" gathering.

In that following session, Kate Cook, associate director for regulations and policy at the Center for Devices and Radiological Health, quickly recapped the workload and the mission of the Center for Devices and Radiological Health, the latter of which she said includes getting "safe and effective devices to market as quickly as possible." She also noted that CDRH is interested in what sort of guidances industry would like to see, remarking, "We get very little input, frankly."

However, most of the session in which Cook participated dealt with the notion of "a level playing field."

Also on the dais with Cook was Steve Terman, a principal at the recently renamed DC law firm of Olsson Frank Weeda Terman Bode Matz, who commented that the "level playing field is a big issue for regulated companies." He said "foreign facilities get inspected way less than domestic facilities," to which Cook responded, "I think it's a matter of public record that this is the case."

Terman also remarked that foreign devices are much more routinely held at the port of entry (by the Customs Service at FDA's behest) whereas FDA requires help from one legal authority or another to put domestically made products into quarantine. This disparity was the topic of a controversy at the beginning of the decade when David Feigal was the director of CDRH, and the controversy still bubbles to the surface from time to time.

Cook said the notion of a level playing field should be patient-centric. "The person we want most to have a level playing field for is the patient or consumer," she said, which entails a focus on safety and efficacy first and the manufacturer second. "The first focus has to be on identifying the risk to the consumer" regardless of nation of origin.

Cook did not come out and say that the lower level of inspections of foreign plants is the reason for the disparate treatment of devices presumed to be faulty or manufactured in non-compliant plants, but her remarks made clear that such is the case. "I have to acknowledge that we do not have infinite resources" to inspect foreign plants because "it's very expensive to conduct a foreign inspection," she stated.

Terman asked whether FDA's perspective on third-party risk-based inspections had changed recently. Cook's response was that federal law states that FDA "could consider things like the results of an ISO audit" to fulfill that requirement, adding that FDA's goal "is to understand when we can rely on other inspection reports and how to evaluate them." This is part of the objective of the pilot joint inspection program that FDA and Health Canada are conducting, but Cook also noted that recently introduced legislation "would attempt to put resources into this and address the inconsistencies you've identified."

Cook also stated that FDA can take the outcomes of previous third-party inspections into consideration when deciding whether to inspect anew under the risk-based inspection paradigm, but the widely held perception is that in order for a firm to qualify for the third-party GMP inspection program, the plant's previous FDA inspection has to have earned a rating of no action indicated.

Also in the audience was Tim Ulatowski, director of the Office of Enforcement at CDRH, who remarked from the back of the room: "I don't want anyone to leave with the impression that these are substitutes for FDA inspections." Regarding any comparability of ISO standards to the quality systems regulations, Ulatowski commented, "it's an issue and GHTF (the Global Harmonization Task Force) is working on this topic," but he offered nothing else.

Another member of the panel, Helen Lewis, director of corporate compliance at Dentsply International (York, Pennsylvania), noted that FDA recently added a requirement for information on testing standards used in development and testing of devices, form 3654. She asserted that the addition has "brought a whole new level of complexity for reviewers" and asked whether ODE has any plan to help reviewers interpret that kind of data.

Cook's response was that "frequently in demonstrating substantial equivalence, a manufacturer will say" they are in compliance with a non-FDA standard, and reviewers need the information "in order to assess the degree to which we can agree with this internationally recognized standard." She stated further that ODE director Tillman would surely know if reviewers were confused by the information.

On the subject of risk evaluation and management strategies (REMS), Cook said that while CDRH has not fully settled on it's approach, "its really a question of how we're going to use these in the coming years," so industry should expect to see a requirement.

She also said the risk communication task force "is important, so I think you'll be hearing about that."

It was Cook who made the observation about the coverage of the in-house meeting by the New York Times. She said "I was astonished to read about it" in the Times, observing wryly that "the fact that CDRH [employees] would look to the Times for a standard calendar reminder is" conspicuous.

"All offices in CDRH have an all-hands meetings" from time to time, Cook said. She added that Tillman went to each of six divisions at ODE last year to give the same talk to each group, but opted to handle it all in one meeting the previous year. "So this really was a standard meeting that addressed things" such as the new administration in the White House and the changes at the FDA commissioner's office. "This was really a regular CDRH meeting, and the fact that it was newsworthy is surprising," she said.

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