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FDA 510(k) Process Provides Framework for Effective Medical Device Regulation

The Advanced Medical Technology Association (AdvaMed) has released a white paper explaining the history and evolution of FDA's premarket notification, or "510(k)," process for medical devices and diagnostics. Approximately 90 percent of the medical devices available in the U.S. have been evaluated by FDA through the 510(k) process allowing patients to have access to essential life-saving, life-enhancing safe medical technology in a timely fashion. FDA clears approximately 3,500 510(k)s per year.

"The 510(k) process has a proven track record in ensuring the safety and effectiveness of medical technology while encouraging device development and meeting the needs of American patients," said Janet Trunzo, AdvaMed executive vice president of technology and regulatory affairs. "Unfortunately, this key regulatory process and the important role it plays in ensuring the integrity of medical devices in the U.S. market is not well understood."

The AdvaMed white paper, "The 510(k) Process: The Key to Effective Device Regulation," outlines the history and evolution of FDA's 510(k) program from its inception with the Medical Device Amendments of 1976 to the present day, explains why the program is an appropriate and effective regulatory approach for the vast majority of medical devices, and dispels some common misconceptions about the program.

The white paper explains how the 510(k)

-Provides an appropriate path to market for devices whose risks are known and whose mitigation measures are well understood;

-Offers FDA significant discretion to apply the necessary degree of regulation and evidence to ensure new devices are safe and effective;

-Facilitates medical device innovation while protecting the public health; and

-Has evolved over the years through continual process improvement to meet the needs of patients and the diversity of the medical technology industry.

Access a copy of the AdvaMed 510(k) white paper at

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.

(Ref : Editorial By Barbara Kram, Editor;

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