Feigal Sees Threats to Device Standards

Originally Published MDDI January 2002WASHINGTON WRAP-UPFeigal Sees Threats to Device Standards

January 1, 2002

12 Min Read
Feigal Sees Threats to Device Standards

Originally Published MDDI January 2002


Feigal Sees Threats to Device Standards

The CDRH director recently expressed doubts about the viability of device standards as a regulatory tool for ensuring safety and effectiveness.

James G. Dickinson

Industry Protests Blood-Test Guidance | A Least-Burdensome Template | Changing the Law—Again | Switching Sides | Others May, but You Can't

wash_wrap.jpgSince the beginning of FDA medical device regulation under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, medical device standards have been the linchpin of this statutory scheme for the majority of products. Their role has also been fraught with problems—Whose standards? Are they adequate? To what extent should FDA rely on them?

Over the years, the agency has accepted many standards for 510(k) devices, and it is seeking to increase its reliance on more standards as a cost-effective and timesaving alternative to data-heavy individual product reviews. But in November, CDRH director David W. Feigal raised serious doubts about the viability of device standards as a regulatory tool for ensuring safety and effectiveness.

He told the annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Baltimore that he has convened an internal task force to review standards-related issues. Feigal said he is puzzled by an apparent avoidance of abbreviated 510(k) submissions that rely on conformance to relevant standards. Using that technique, "you can have a one-page 510(k)," he explained; still, 84% of submitters do not cite their conformance to recognized standards.

Although he emphasized his own belief in the importance of standards to a globalizing device industry, Feigal acknowledged that an internal CDRH study had shown that conformance-to-standards 510(k)s are not reviewed more rapidly than traditional 510(k)s. This, he said, could be one explanation for industry avoidance. That same study, however, showed that 46% of traditional 510(k)s contained "embedded" standards that could have saved the manufacturers effort in preparation of their 510(k)s.

Feigal said he also saw many threats to the continued use of standards by the device industry. Among these are trade politics, distrust of standards among other FDA centers that see them as not being part of an open and transparent process, the copyrighting of standards, a legal threat in a current suit that claims a developer of swimming pool standards is liable for a user fatality, and skepticism about whether standards represent the "trailing" or "leading" edge of technologies.

In spite of the overwhelming tendency of manufacturers not to use abbreviated 510(k)s that assert their conformance to standards, Feigal said CDRH has nevertheless seen a positive trend. Abbreviated submissions have risen from just six in 1996, to 154 in 2000, to 617 in FY 2001.

Echoing frustrations expressed to RAPS the day before by CDRH quality systems expert Kim Trautman, Feigal asked the rhetorical question of whether the International Standards Organization (ISO) can continue to be of service to the industry while it emphasizes customer satisfaction as a product standard.

Trautman had told RAPS that FDA and a few of its foreign regulatory agency partners are debating whether the medical device industry should break away from a voluntary standards process—mainly ISO 9000 and related standards that have been or are currently being revised. Blaming the influence of consultants and ISO's own revenue-raising ambitions through its training programs and certifications, she described as "artificial" recent changes to ISO 9001 (2000 revision) and an accompanying document on quality management systems, ISO 13485 (200X), which is under draft revision.

Feigal also used his RAPS podium to address third-party 510(k) submissions, saying that after initial industry hesitancy to pay for non-FDA reviews, third-party reviews had lately seen a boost from 47 in 2000 to 107 in 2001. Review times were consistently better for third-party submissions than for in-house reviews, averaging about a month shorter, Feigal said.

FDA has found third-party reviews to be at least as good as CDRH reviewers, Feigal added. In fact, he is so impressed with the quality of their work that he has asked for budget funding to use them as primary device reviewers in times of workload crises at the center.

Asked about extending this principle to device inspections, Feigal said he would "love it," but it would require a change in the law.

Industry Protests Blood-Test Guidance

The Advanced Medical Technology Association (AdvaMed) has commented on a recent FDA Center for Biologics Evaluation and Research (CBER) draft guidance on automated blood-testing instruments used in blood banks, the Draft Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments. AdvaMed says the guidance requires manufacturers to prove that such a medical device is safe and effective instead of substantially equivalent to a device that is already legally marketed.

In November comments to the agency, the group said that the guidance's recommendation regarding the information required in these types of 510(k) submissions "goes beyond the legal responsibility that CBER has in regards to review of 510(k) submissions." It also said the guidance is "contrary to the purpose of a 510(k) as well as the intended purpose of the guidance document created."

AdvaMed said that CBER appears to be applying, without any legal justification, BLA or PMA requirements to these types of submissions simply because of the operation and location of the device. The group argued that the guidance is an example of CBER ignoring the FDA Modernization Act's least-burdensome provision and if adopted as drafted, the guidance would cause longer review times for these devices.

A Least-Burdensome Template

Fast on the heels of CDRH director Feigal's public focus on standards and their key role in low-burden abbreviated 510(k)s, the center announced its development of a special controls guidance document. The document is intended to reduce "immediately" the regulatory burden of getting indwelling blood gas analyzers to market. The center said it saw the document as having a dual purpose, in that it also serves as a possible template for special controls guidance documents for other device types.

Entitled Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA, the document was developed to support reclassification of these preamendment devices from Class II to Class III. It is only the second CDRH guidance to take full advantage of the abbreviated 510(k) concept (the first was Latex Condoms for Men: Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions). It can be accessed at http://www.fda.gov/cdrh/ode/guidance/1126.html.

CDRH said that while the new document for indwelling blood gas analyzers also relies heavily on recognized consensus standards, it is designed to take advantage of the 510(k) paradigm's concept of a "summary report," described in detail on-line at http://www.fda.gov/cdrh/ode/parad510.html.

In its November statement, CDRH said FDA may consider the contents of a summary report to be appropriate supporting data within the meaning of 21 CFR 807.87(f) or (g). "In appropriate circumstances," the statement explains, "a summary report will be an efficient way for a 510(k) submitter to describe the methods used and the acceptance criteria applied to address the risks identified in a special controls guidance document, as well as any additional risks that may be specific to a particular device. A 510(k) that includes such a summary report relies less on a side-by-side comparison to another legally marketed device and more on addressing the risks that are known to exist with devices of the same type."

Changing the Law—Again

CDRH's Phil Phillips and AdvaMed's Janet Trunzo agreed on several things during a panel discussion in November—including that the four-year-old FDA Modernization Act (FDAMA) has been largely successful in its objective of improving the regulatory process and fostering greater agency accountability. They also agreed that more improvements need to be made, some of which will require new legislation.

Phillips, who is deputy director of CDRH's Office of Device Evaluation, and Trunzo, AdvaMed's director of technology and regulatory affairs, shared the podium on the final day of the annual RAPS conference in Baltimore for a discussion of FDAMA and what many think needs to follow it—FDAMA II.

Trunzo, who serves on an industry working group that is preparing legislative proposals to achieve such an act, offered a preview to some of the significant changes that may be in store. For example, she said an innovative approach to inspections—one that mirrors the now-functioning third-party premarket review process—would allow companies with good inspection records to select a third party to conduct in-plant inspections. "FDA would, of course, have to qualify third parties in order for them to serve as inspectors," she said. "This would relieve the burden on overworked FDA staff and greatly enhance the agency's ability to ensure that facilities are inspected on a timely basis."

Phillips cited a number of quantitative agency accomplishments under FDAMA, including the publication of six final rules and 22 guidance documents, recognition of more than 400 consensus standards, and approval of 13 third parties qualified to perform 510(k) reviews. He said the agency has expanded its outreach to stakeholders, including consumers, and has made a major effort to expand access to investigational devices through its emergency and "compassionate use" authorities.

Other amendments to FDAMA suggested by Trunzo, and that may be incorporated in a legislative proposal supported by AdvaMed, include provisions to achieve the following:

  • Establish an office of combination products and product designation, which would report to the FDA commissioner. The intent would be to streamline the review of combination products, now often delayed because of the need to coordinate reviews across multiple FDA centers.

  • Expedite the review of breakthrough devices by giving them preferential position in the review queue, enhancing FDA's review resources by authorizing review by outside (nongovernment) experts, and creating a requirement for a 120-day review period.

  • Expand third-party reviews of 510(k) devices by eliminating restrictions on eligibility—particularly on devices for which clinical data are available.

  • Augment FDA's ability to process PMA applications by allowing firms to voluntarily select an outside expert—one who has been qualified by FDA—to perform the review. If this option is elected, the device company would pay the expert's fee.

  • Institute an FDA fellowship program, through which the agency could offer temporary positions to individuals possessing urgently needed skills and scientific expertise. Individuals selected for fellowships would have to satisfy FDA's conflict of interest requirements.

In his comments to RAPS, Phillips did not elaborate on areas for new legislation that FDA would support.

Switching Sides

CDRH Division of Cardiovascular and Respiratory Devices director James E. Dillard III left FDA to join the U.S. Smokeless Tobacco Co. (Greenwich, CT) in mid-December. Dillard is now vice president for science and technology at the firm.

Dillard began his career with FDA in 1987 and has held several positions within CDRH's Office of Device Evaluation. At U.S. Smokeless Tobacco, he will be responsible for managing and advancing the company's science and technology resources, the company said in a statement. The company manufactures moist tobacco products, such as Copenhagen and Skoal.

Others May, but You Can't

Device makers distributing products in the United States are not afforded the full benefits offered by the FDA-endorsed Global Harmonization Task Force (GHTF) guidance document on process validation. The guidance includes an option that allows for skipping process validation for process outputs that are not fully verifiable if the potential risk to patients is low; U.S. companies marketing products within the country are not afforded this option, however, and must fully validate each process.

The risk-based option from the guidance's process validation decision tree has led to some confusion among device companies, CDRH international staff director Christine Nelson told the RAPS meeting on November 6. She stressed that "FDA requires processes to be validated if the processes cannot be fully verified."

FDA encourages device manufacturers to use the GHTF process validation guidance and has taken steps (such as having a speaker at the RAPS conference) to communicate to industry that the agency recognizes the document. The guidance was designed with input from FDA and its international regulatory counterparts in the EU, Canada, Japan, and Australia. It is intended to assist device makers in understanding process validation requirements and covers manufacturing, servicing, and installation processes.

Nelson outlined examples of processes that the document and FDA required to be validated. These include:

  • Sterilization.

  • Cleanroom ambient conditions.

  • Aseptic filling.

  • Sterile packaging sealing.

  • Lyophilization.

  • Heat treating.

  • Plating.

  • Plastic injection molding.

By following the guidance process validation decision tree, manufacturers can determine if a certain process needs full validation or could be controlled through verification. Some examples that Nelson said could be verified include manual cutting, testing for color or total pH for solutions, circuit board visual examination, and manufacturing and testing of wiring harnesses.

Nelson told RAPS that some device companies have used supplier qualification studies as a substitute for "installation qualification," which is intended to ensure that equipment has been installed correctly. She said these studies should not be viewed as a replacement for validation, but they can be used as guides, to obtain basic data, and to support installation qualification.

The guidance can be downloaded from the GHTF Web site at http://www.ghtf.org.

Copyright ©2002 Medical Device & Diagnostic Industry

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