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Originally Published December 1998

OUR VIEW

The New FDA: What You Need to Know

The new law has implications for labeling.

On November 21, 1997, President Clinton signed the FDA Modernization Act of 1997, known as FDAMA. The legislation resulted from nearly three years of intense lobbying, bitter debate, and tough negotiations among members of Congress, the regulated industries, FDA, and others. The medical device industry was front and center during the deliberations, with significant leadership from HIMA, the world's largest medical device trade association.

Several years ago, the device industry was in crisis. Important new products were being held up at FDA, the review process was inconsistent and unpredictable, and the agency's lack of communication with manufacturers symbolized the intransigence of the bureaucracy. Not surprisingly, the resourceful industry looked to other, less burdensome venues to test and market their products. Some critics genuinely believed that much of the United States' world-renowned scientific and medical infrastructure would be lost to other nations.

Faced with this crisis, HIMA worked with members to advocate measures to modernize FDA. The goal was to provide the agency with the tools to work better and more efficiently. Those tools were codified in FDAMA.

The act has implications for labeling. For one, it limits FDA's review of intended use issues by addressing those instances where reviewers might ask questions—or even require documentation—about potential device uses not specifically contained in the labeling. In the past, such types of questions resulted in unnecessary delays. Now, the law allows them to be raised only if there is a finding of off-label use and a determination that such use could cause harm.

Another provision relates to the use of an FDA mark or seal on a label. It was formerly prohibited to state or suggest FDA approval for devices granted premarket approval (PMA) or an investigational device exemption (IDE). FDAMA repealed that prohibition but did not address a similar one for premarket notification 510(k) devices. The agency could repeal the regulation and specify language that recognizes the unique nature of a 510(k) device, such as, "This product conforms to the Food and Drug Administration's legal requirements for marketing." However, the agency has not chosen to do so yet. HIMA has objected to a recent FDA proposal to collect a fee for use of its seal on PMA and IDE devices.

Other labeling issues not addressed in FDAMA include a labeling initiative proposed in April 1997 and the latex labeling final rule, which took effect September 30, 1998. The labeling initiative has drawn sharp criticism from HIMA and other parties. The agency proposed that all products bear a summary of key information, titled "Highlights of Labeling Information."

The latex labeling rule requires manufacturers to include warnings on all latex-containing devices, including components and packaging, that are intended to or likely to contact humans. Packages that contain cold-seal adhesives on their flap must comply by June 30, 1999. Since the rule applies to all levels and all sizes of packaging, no matter how small, HIMA is working to secure approval of a symbol that might be used in lieu of the warning language.

FDA must be given credit for its aggressive and timely implementation of FDAMA. The agency has produced dozens of guidance documents, notices, and regulations explaining the new law. HIMA will continue to work with the agency to ensure that the true spirit and purpose of FDAMA are realized.

Susan K. Zagame is vice president for technology and regulatory affairs, Health Industry Manufacturers Association (HIMA)

This article was adapted from remarks made at the IBC conference on medical labeling, October 22, 1998, in Palm Beach Gardens, FL. More information on FDA's implementation of FDAMA can be found at http://www.fda.gov/cdrh. Information about HIMA can be found at http://www.himanet.com.