WASHINGTON, D.C. - The Advanced Medical Technology Association (AdvaMed) urged Congress to take a more targeted and risk-based approach to ensuring the health and safety of the American public is not compromised by medical devices imported into the U.S. Such an approach would ensure the FDA could address its inspection priorities while preventing unnecessary delays in patient access to life-saving, life-enhancing medical technologies.

"AdvaMed believes inspections are a core function of the FDA and funding should come from the appropriations process, not industry fees," said Stephen J. Ubl, president and CEO of AdvaMed, testifying before the House Energy and Commerce Committee Subcommittee on Health regarding the discussion draft of the FDA Globalization Act.

The association said the draft legislation would impose a new user fee on all foreign and domestic manufacturers of moderate- and high-risk medical devices to help pay for FDA inspections. Ubl cautioned of the unintended consequences of such a broad based user fee.
"Many of our members, particularly small companies, do not have foreign facilities, yet through their fees they would effectively subsidize inspections of foreign companies exporting their products to the U.S.," said Ubl.

Instead, Congress should consider crafting "a targeted funding mechanism for inspections of foreign facilities that are located in countries with less developed regulatory systems and actually export products to the U.S."

In his testimony, Ubl also asked Congress to reconsider a provision in the draft legislation that would require FDA to conduct pre-approval inspections for all moderate risk (class II) devices. "With more than 3,600 class II devices cleared each year by the agency, the FDA approval process would come to a screeching halt if this proposal were implemented," he said. Instead, industry favors the agency's current "risk-based approach" to inspections for facilities manufacturing these products.

In addition, Ubl testified it would further stress FDA's inspectional processes to mandate that FDA perform "catch-up inspections" of the estimated 10,000 facilities manufacturing moderate- and high-risk devices within two years. "This is a further example of how a risk-based approach to inspections would better serve the needs of patients while addressing inspection priorities," said Ubl.

AdvaMed also supports a change in the statute that would allow FDA to accept manufacturers' certification to internationally accepted quality systems standards in place of the agency's quality systems inspections. Such a move would help globalize the agency's efforts to harmonize its requirements with those of other developed countries, he noted.

Ubl expressed support for the Committee's work and pledged to work with Members of Congress to help refine the draft legislation to ensure it achieves its objective to improve public health and safety.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org

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