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Careful Study Marks Henney's First Months : Burlington "Will Be Missed Severely" : "Least-Burdensome" Device Rules Discussed : At Least Have a Plan, Says FDA : Few Takers for New 510(k) Paradigm : Could MedWatch Form Revision Hurt Y2K?

Medical Device & Diagnostic Industry Magazine
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An MD&DI April 1999 Column

The new FDA commissioner plays it close to the vest while expressing a willingness to work with the industry.


  • Burlington "Will Be Missed Severely"
  • "Least-Burdensome" Device Rules Discussed
  • At Least Have a Plan, Says FDA
  • Few Takers for 510(k) Paradigm
  • Could MedWatch Form Revision Hurt Y2K?

In sharp contrast to her predecessor, who hit the deck running and quickly grasped all media opportunities to promote his agenda, new FDA commissioner Jane Henney has kept a low profile as she has carefully studied the state of the agency during her first few months in office.

Some of Henney's conduct is certainly due to native reserve and caution, but some has been forced on her by circumstance. She is rediscovering an FDA that has far fewer resources than the one she left in 1994, after serving as David Kessler's deputy for operations for two years. She has also found that all parts of the agency are fully engaged with implementing the FDA Modernization Act (FDAMA), which is her publicly stated top priority. And she has doubtless realized that FDA's command structure—in the political vacuum left by Kessler's departure—was "occupied" by the HHS Office of the Secretary, leaving it with less autonomy than top managers had been used to having when Kessler was there.

On top of all this, Henney's practical ability to effect immediate changes in the agency's top management has a new limitation with which Kessler never had to contend. The Treasury Employees Union has taken over the agency's career employees and must be negotiated with concerning all organizational and process-based planning.

As part of her refamiliarization with the agency, Henney in December visited FDA's Denver district office and then spoke with members of the local medical device industry, under the auspices of the Colorado Medical Device Association (CMDA), at a meeting held in the law offices of Chrisman, Bynum & Johnson in Boulder. During a 25-minute question-and-answer period, Henney hedged most of her responses by reiterating her need to gather more information. She was well equipped, however, to field a question about the industry's reported tendency to move R&D offshore to gain faster approvals—as, for example, Medtronic was said to have done with at least 15 products.

Henney replied that there was undoubtedly more to this offshore trend than the timeliness of the review process, citing two recent examples of devices that had been approved by FDA and marketed within a few months of submission.

To a question about FDA's budget, Henney noted that some parts of the agency were well funded by user fees whereas others were short of resources. She maintained that, before making any recommendations, she would have to study the matter further to see where additional resources were most urgently needed. Henney also begged off when asked about device reprocessing, saying she would check into this area to learn what was going on. And when asked by CMDA president Dick Hanson about the possibility of combining FDA and EU requirements to ease the burden on industry, Henney again said she needed time to catch up on the issue.

In general remarks to CMDA, the new commissioner expressed her willingness to continue FDA's cooperation with the medical device industry. She particularly noted the importance of carrying on the progress of the joint FDA-industry task force that has been working on the agency's grassroots regulatory partnership program.

CDRH director Bruce Burlington, who left the agency in mid-March, "will be missed severely," according to Health Industry Manufacturers Association executive vice president James Benson. Burlington, an 18-year FDA veteran, is leaving to head up regulatory affairs at Wyeth-Ayerst Pharmaceuticals in Philadelphia. He is credited with reorganizing FDA's generic drug program after it succumbed to scandal in the late 1980s, with leading internal efficiency efforts in the review of drugs and devices, and, as CDRH director since 1993, with cutting review backlogs and increasing productivity by 40%.

Benson commented that Burlington was sometimes accused of implementing a drug model for devices, but noted that, overall, "I don't think we were at odds," and called Burlington's term at CDRH "good for industry."

What is FDA expected to make of Congress's industry-cheered directive in FDAMA section 205 enjoining the agency to consider the "least-burdensome" means of assuring that medical devices are effective enough to go to market? Following a January 4 meeting requested by the device industry to discuss this provision of the law, CDRH's Office of Device Evaluation (ODE) is waiting to see if industry will produce a draft guidance document, as promised, before drafting one of its own.

"We had a very successful meeting," says ODE director Susan Alpert. "Many of the FDA people who were there listening told me they learned about industry concerns that they weren't sensitive to before. They know industry wants something that can be looked at, referred to, relied on, and discussed."

Alpert said that the specific design of a document was not discussed. She did mention one possibility: a flowchart that would raise questions FDA staff should consider in determining, first, what evidence is really needed for any particular device, and second, what is the least-burdensome way to obtain the evidence required to make a decision.

Alpert's assessment of the meeting was echoed by HIMA executive vice president James Benson and Medical Device Manufacturers Association (MDMA) executive director Stephen Northrup, both of whom said they believed the agency better understood industry concerns and showed a willingness to consider them.

Disagreement continues, however, over FDA's arm's-length policy of not sitting down with industry to work out the nuts and bolts together. The January 4 meeting, for instance, focused on industry concerns and the ways those concerns could be addressed, not on specific language that might go into a guidance document—even though, according to MDMA's Northrup, Alpert acknowledged the possibility of inconsistencies among individual reviewers as to what studies may actually be needed to make a determination concerning effectiveness for a particular device. Benson stated that he hopes commissioner Jane Henney will revisit this policy; Northrup also said he did not like the policy but that it was too late to do anything about it, since almost all materials that could have been discussed collaboratively if the policy had not been in place are now in the pipeline.

"We've done it this way because sometimes not everyone can get to the table for discussion for a variety of reasons," Alpert explained. "Our thinking has been that it's best if the agency puts something out in writing, and then everyone who is interested has equal access to it and equal opportunity to comment, to influence the decision, to have an impact."

Benson volunteered for HIMA to take the lead in forming a working group of all interested parties (except FDA) to discuss what could go into some form of guidance document and then to submit such a document to FDA. Alpert said the agency would be happy to receive such a draft "straw man" and would consider its contents during the creation of whatever will be produced. "If we hear that industry isn't going to produce something, then we will go forward and put our ideas down and put them out for comment," she continued.

While there seemed to be agreement on basic themes at the meeting, differences of opinion did arise. David Sampson, appearing on behalf of the Blue Cross/Blue Shield Association and its Technology Evaluation Center, cautioned against weakening current standards for premarket approval (PMA) devices and asserted that an industry-led task force is "not warranted or appropriate. FDA is the proper body to design process improvements should they be needed."

FDA, Sampson said, must "maintain and perhaps even strengthen its standards for evidence of clinical effectiveness to ensure that FDA-approved technologies provide clinical benefit to patients."

Northrup countered that industry does not desire to "weaken or subvert the gold standard of FDA or the high regard in which it is held around the world" but only wants FDA to require use of the least-burdensome means of meeting existing standards. Benson said he will invite Blue Cross/Blue Shield to participate in the working group if they are interested in contributing to a draft guidance document rather than in trying to prevent such a document from being developed.

After the meeting, Alpert commented that some industry representatives who spoke seemed to believe that standards could be changed or that the agency had to justify its requirement for particular types of trials. Her response, she said, was that the agency does not read the law that way.

Scottcare Corp. (Cleveland), manufacturer of the Tele-Rehab II cardiopulmonary monitoring system, received one of the few warning letters sent by FDA to companies not making progress in coming into compliance with the new quality system regulation. "The letter covered all design controls," Cincinnati district compliance officer Lawrence E. Boyd said. "They basically had nothing in place. They hadn't changed anything."

Boyd said that companies hoping to avoid warning letters more than six months after the new regulation took effect should at least have drafted procedures explaining what they will do to come into compliance. "They should have a plan to describe what they're going to do and specifications for how they will change a design if that's needed."

Why aren't device companies jumping at the chance to submit less rather than more data under CDRH's premarket notification (510(k)) paradigm? An internal agency task force has convened to find ways of jump-starting this innovative program, under which the center is accepting reduced-data "special" 510(k) device modification submissions bearing declarations of conformance to design controls and recognized standards. The paradigm also allows "abbreviated" 510(k) submissions for new devices with summary data and conformance declarations to recognized standards or an agency guidance.

One criticism CDRH has heard about its new program is that conformance to standards is required at the time of submission, something that may not be practical for certain devices.

CDRH's Office of Science and Technology director Harvey Rudolph agrees. He says that for certain products—like diagnostic imaging devices—FDA will probably allow manufacturers to simply certify that the devices will conform to standards once they come off the assembly line.

For years, the center has accepted 510(k)s for these types of products based entirely on the design of the device, and Rudolph says there are many other devices that can fit into this category. The details are still being worked out in the center, but Rudolph is confident that this approach will be adopted and should help with more paradigm submissions.

Center officials speculate that many in industry are still not aware of the paradigm program, and CDRH will look to increase its communications outreach, educating manufacturers on the benefits of abbreviated and special 510(k)s. Conformance to standards is also available to PMA application submitters as a result of FDAMA, Rudolph says.

Industry may be reluctant to test the new waters because of concerns that a submission could influence an FDA investigator to audit data related to the declaration of conformance. Rudolph says that whereas a few special 510(k)s were audited recently, most of the investigations were part of routine scheduled inspections. He doesn't expect conformance declarations to trigger an inspection—rather, the majority of audits will be tacked on to scheduled quality system inspections.

Rudolph anticipates an upswing in new paradigm submissions now that FDA has recognized additional standards. Although the first group of standards probably did not result in a significant reduction in submitted data, Rudolph says that the second group will definitely bring about substantial cuts. Submissions incorporating these latter standards will probably be seen beginning in about a month.

Because revisions to FDA's MedWatch Form 3500A, proposed by the agency last November, are not "critical" and would produce only marginal benefits, if any at all, FDA should defer the rule-making process until after industry has emerged from the Y2K crunch, HIMA urged in January 11 comments.

Many companies have invested in computerized versions of form 3500A that would require significant time and resources to modify to the new format, HIMA argued. The process would be further complicated by integrated computer links to other company operations. "For example, some companies have established a searchable database that will automatically retrieve information located in specific boxes of former 3500As that have been completed and submitted to FDA," the association said. The new format would make the databases useless.

HIMA gave another example, one involving computer programs that directly transfer complaint-handling system data to a computer-generated form 3500A. Significant reprogramming would be necessary, HIMA said, to maintain and validate this type of operation.

No changes should be made to the form until at least the year 2001, HIMA told FDA, adding that when changes are proposed they should be developed in consultation with stakeholders—the way form 3500A itself was developed.

In other comments on the proposed revisions, Schering-Plough Research Institute (Kenilworth, NJ) asserted that the changes are mostly cosmetic, conferring no obvious value added, and urged FDA not to proceed. The changes "will impose significant cost to industry to reprogram and revalidate existing systems that generate the computer facsimiles of the MedWatch form," wrote Barton L. Cobert, MD, the institute's senior director of medical and safety services.

Copyright ©1999 Medical Device & Diagnostic Industry
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