Lightening the Regulatory Burden : Does FDA's Export/Import Guidance Go Too Far? : Focus on Risk Management : In Europe, FDA Will Abide by FOIA : FDA Updates Consensus Standards Guidance : Old Won't Fit into New : Device Firms Need Design Control Procedu

James G. Dickinson

March 1, 1999

10 Min Read
Lightening the Regulatory Burden : Does FDA's Export/Import Guidance Go Too Far? : Focus on Risk Management : In Europe, FDA

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

9811d30a.jpgDefining "least-burdensome" concept is turning out to be quite a burden.


  • Does FDA's Export/Import Guidance Go Too Far?

  • Focus on Risk Management

  • In Europe, FDA Will Abide by FOIA

  • Old Won't Fit into New

  • FDA Updates Consensus Standards Guidance

  • Device Firms Need Design Control Procedures

  • Henney Revamps Commissioner's Office

  • Deputy Commissioner Schultz Leaves

Reversal of the Kessler-era mission to "take science up a notch" at CDRH may be the new policy direction under the FDA Modernization Act (FDAMA)—but don't expect anyone to actually say so.

Instead, industry presentations to a January FDA public meeting—and careful reticence on the part of FDA officials—seem to invite the assumption that FDAMA's section 205 now relieves industry of the need to provide clinical evidence of effectiveness for a premarket approval (PMA) device or extensive other data for a premarket notification (510(k)) device, except in unusual cases.

Section 205, popularly dubbed the "least-burdensome" rule, requires FDA to "consider" reducing the extent of data to be required "through reliance on postmarket controls," and, with respect to clinical data that may be needed, to "consider, in consultation with the applicant, the least-burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval."

That's pretty explicit, but it still leaves wiggle room for bureaucrats. All Congress can do is direct FDA to consider—it can hardly order it to heed or follow. This sobering reality is what provoked the two main industry groups, the Health Industry Manufacturers Association (HIMA) and the Medical Device Manufacturers Association (MDMA), to each draw heavily in recent pronouncements on the same solitary word that lawmakers and others have been pointing, post-FDAMA, like a weapon at FDA's head: spirit, as in "the letter and the spirit of the law."

FDA officials have not been using that word very much themselves as they review their options, but new commissioner Jane E. Henney has used it a lot in assuring FDAMA's principal architect, Labor and Human Resources Committee chairman Senator James Jeffords (R–VT), that her top priority will be to implement FDAMA fully, in the way Congress intended.

In January, the two industry associations criticized heavily FDA's Kessler-era tendencies of requiring more and ever-deeper scientific and technical data for device applications. The groups extolled section 205 as both a restatement of Congress's long-standing mandate to avoid overregulation of devices and the cornerstone of the entire legislation.

HIMA announced that it would facilitate an all-parties task force to look at situations in which randomized trials are unnecessary to demonstrate effectiveness. The task force also will examine ways to help refine FDAMA's "least-burdensome" effectiveness concept in various device contexts such as vagus nerve stimulators, antimicrobial-coated cardiovascular implants, a breakthrough therapeutic device, and a diagnostic device intended to diagnose a life-threatening disease or condition.

The task force will then develop a general protocol for use by each Office of Device Evaluation division in determining the least-burdensome valid scientific evidence. The protocol will include detailed written procedures and accompanying flowcharts for determining the least-burdensome approach. MDMA, for its part, stressed that the onus is on FDA to cease its use of randomized clinical trials as a default requirement, and that a meaningful procedure for dispute resolution needs to be established.

FDA maintains that its draft guidance for industry on exports and imports under the FDA Export Reform and Enhancement Act of 1996 reflects current practices to the extent that they exist and meets the needs of the various centers. Industry representatives aren't so sure.

Comments submitted by HIMA claim there are portions of the guidance that seek to establish additional requirements and therefore need to be deleted. As an example, it cited recommendations on how a manufacturer can demonstrate that a product does not conflict with the laws of the importing country and is not sold or offered for sale in the United States. In each instance, HIMA says the agency is being overly restrictive in its guidance, while agency officials say the guidance sets forth past practices yet is flexible.

Whereas FDA suggests that a company obtain a letter from a foreign government agency stating that the product has marketing approval in that country or does not conflict with the country's laws, HIMA responds that statutory language does not restrict the methods by which such demonstration is to be made.

CDRH's deputy director for program operations, Wes Morgenstern, states that FDA has "always told firms that they must obtain permission from a government official if such permission can be obtained." He added that CDRH maintains a list of countries that won't cooperate with the requirement and tells manufacturers to check the list and report if they are having problems getting an approval letter, whereupon FDA will allow an alternative.

Another bone of contention is the guidance's suggestion that, in order to show that a product is not sold or offered in the United States, a firm could submit a label stating "Not for sale in the United States." But HIMA retorts that such a practice would turn the demonstration into a mandatory labeling requirement. Morgenstern says the label idea was just an option: "The primary means of proof should be careful records. The company should have very good records that show what goes in and what comes out. It's as simple as that."

CDRH's Office of Compliance is planning a series of industry training seminars that will focus on risk management. Risk management covers everything from device design to manufacturing to marketing. Training will emphasize total risk management, and not focus simply on design control. There are many areas in the regulations that require risk-based decision making, and companies will need statistical tools and science-based techniques to comply. AAMI is also working on standards for risk management.

Under the recently concluded Mutual Recognition Agreement (MRA) with the European Union (EU), any information collected for FDA by an MRA partner that would be releasable under the U.S. Freedom of Information Act (FOIA) if gathered in the United States will in fact be subject to release by FDA under that statute.

That is one conclusion drawn from dozens of pages of FDA correspondence prepared in response to scores of questions from the House Commerce Oversight and Investigations subcommittee. However, unlike home-ground inspections, FDA will only get documents from EU members if it explicitly requests them in each case.

The question of FOIA document release was a potential deal breaker that threatened to wreck the MRA at one point, but the Europeans relented after their local industries agreed to yield to U.S. practice and law in order to consummate the agreement.

On trade-secret protection, however, FDA yielded to local laws about which it knows little. "Samples and analytical data will be handled according to the laws of the country in which the material was collected," FDA told the subcommittee. The agency said that each party to the MRA would use its current procedures to determine what is trade-secret information. The MRA, it added, "directly addresses sharing of inspection reports, not other types of 'evidence,' during the operational period."

The correspondence with the subcommittee makes plain that, although FDA won on FOIA, it signed the MRA with little knowledge about the equivalency of various EU regulatory systems that will be crucial to the MRA's success. Addressing the accountability of its counterpart agencies in the EU, FDA said it "does not know to whom member-state regulatory authorities answer, but it will closely examine this during the transition period and thereafter." The agency also said it does not know all the member-state laws that may be used to remove products from the market, but noted that under Article 13 of EEC Directive 91/35, six member states "may rely on complaints and mandatory recalls." FDA said it would determine whether this provides equivalent protection from unsafe products.

In addition, FDA professed ignorance as to whether there are different standards in EU countries for companies that are owned in whole or in part by sovereign governments but said it "intended to consider this issue when conducting its equivalence assessments." The question is important, because one criterion for assessing equivalence is the avoidance of conflicts of interest—for example, would a government that owns its own drug company be equivalent to FDA when it inspects that company for FDA?

"At this time," the agency said cagily, "FDA is not in a position to speculate whether this issue would preclude a particular regulatory authority from being determined equivalent." FDA also acknowledged that the MRA does not define conflicts of interest, so FDA will use its own codified standards when assessing EU regulatory agencies for such conflicts.

FDA has expanded its guidance on "Frequently Asked Questions on Recognition of Consensus Standards" to help device manufacturers with abbreviated and special 510(k) submissions under CDRH's new paradigm.

When it comes to FDA's new quality system design control regulations, device companies are finding that old ways aren't convertible.

According to GMP and quality systems expert Kim Trautman at CDRH, field investigators in the first six months of auditing have found that too many firms are trying to superimpose their existing engineering change control order and notice systems onto the new regulations.

Trautman said that when firms use existing change control orders or notices, they are not tying back to the design control requirements as they should, "so there are a lot of linkages and ties that are missing."

According to Trautman, change control orders and notices are very strict systems attuned more to documents and drawings, making them harder to fit to concepts or to improvements to devices. "People are trying to fit something they are comfortable with into something that needs to be broader and more flexible."

In auditing design control requirements, FDA has so far been lenient. Trautman estimates there have only been six warning letters covering design control violations, and they have targeted only the most egregious violators—firms that did not have any design control procedures at all. It appears that FDA recognizes that there is still a learning curve for everyone, including the agency itself, says Trautman, and will be content for now to focus on serious violators.

FDA Cincinnati District compliance officer Lawrence E. Boyd says medical device companies that have not yet done anything to comply with new quality system design control regulations should develop procedures for implementing the regulations if they want to avoid a warning letter. "They should have a plan to describe how they'll do it," he says, "and specifications for how they will change a design if that's necessary." Warning letters have been sent to a half-dozen firms nationwide that had not addressed the regulations at all since the June 1, 1998, start of design control audits. One of those letters was sent in December to Scottcare Corp. Inc. (Cleveland), which, according to Boyd, was the most egregious violator.

As soon as she arrived at FDA in December, commissioner Jane E. Henney appointed deputy commissioner for strategic management Linda Suydam to head a task force to recommend a new organization plan for the Office of the Commissioner, which had come under criticism for being too large and inefficient. Suydam told FDLI that she and the other three members of the task force—Center for Food Safety and Applied Nutrition director Joe Levitt, the Center for Veterinary Medicine's Bob Sauer, and associate commissioner for planning and evaluation Paul Coppinger—would report to Henney sometime in early 1999.

FDA deputy commissioner for policy William B. Schultz, who had been a candidate for commissioner before Jane Henney was chosen, left the agency effective January 1 to assume a senior legal position in the U.S. Attorney General's office.

Schultz came to FDA in February 1995 at the invitation of then-commissioner David A. Kessler. Schultz's service was warmly praised December 16 by Senate Judiciary Committee chairman Orrin Hatch (R–UT) during a speech at FDLI's Annual Educational Conference. Hatch said that while he "often disagreed" with Schultz, the latter possessed "integrity, knowledge of the law, tenacity, work ethic, ability to reach compromise, and . . . absolute devotion to advancing the interests of the public."

Schultz had previously been counsel to the House subcommittee on Health and Environment, and before that served 13 years with Ralph Nader's Public Citizen Litigation Group.

Copyright ©1999 Medical Device & Diagnostic Industry

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