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FDA Compliance

Independent Testing and the FDA

Published: Tuesday, March 25, 2008 - 22:00

(UCSF: San Francisco) -- The approval process for medical devices doesn’t involve the same rigorous review used for pharmaceuticals, and to improve health outcomes this needs to change, say researchers from the University of California, San Francisco.

In the January 2008 issue of the Journal of General Internal Medicine, the UCSF team analyzed the problem and concluded that after a device achieves Food and Drug Administration (FDA) approval, a technology assessment by an independent organization can help identify medical devices that are truly beneficial and safe.

The UCSF analysis evaluated the federal review process, the method by which devices come to market, how the scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology’s medical benefit to patients.

Out of the thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the kind of scrutiny required for new drugs, according to information cited in the report. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Plus, the agency relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology isn’t beneficial or is potentially harmful to patients, the report states.

“FDA approval should be the start of the process toward clinical application, not the end,” says Mitchell D. Feldman, M.D., professor of medicine at UCSF and corresponding author of the study. “Physicians and patients just aren’t aware of the limitations of the FDA process of initial assessment and oversight of new medical technologies. Assessments by objective entities are a necessary addition to FDA approval, so that deficiencies in clinical evidence, and patient safety issues that may arise after approval, are recognized before widespread adoption into clinical practice.”

According to Feldman, the purpose of independent review organizations is to provide transparent, objective evaluations of new medical devices and to inform the public, physicians and policy makers. Some, such as the California Technology Assessment Forum (CETAF), have meetings open to the public and populate their review board with experts in medicine, representatives from medical professional societies, technology manufacturers, policy makers and insurance providers, among others. CTAF selects devices for review based on their impact and the availability of relevant clinical data.

“In order to be considered in an assessment, CTAF requires that information already be published or accepted by a peer-reviewed journal. This encourages companies to make their trial results available to the public,” says Jeffrey A. Tice, M.D., attending physician in the division of general internal medicine at UCSF and co-author of the study. “CTAF also requires improvements in patient-oriented outcomes, not surrogate markers. For example, we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size.”

The researchers also suggest that this assessment follow an evidence-based approach to information-gathering that includes data on the device’s success in clinical application. This type of data would be valuable for increasing health professionals’ awareness of “the potential promise and pitfalls of new technology,” the team writes.

For further information, visit http://pub.ucsf.edu/newsservices/releases/200801301/


About The Author

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The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.