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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 http://www.advamed.org
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;
http://www.dotmed.com/news/story/6775)
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