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FDA Compliance

FDA Asks for Public Comment on Pathway to Lower-Risk Medical Devices

Agency continues to seek improvements to the device review process

Published: Wednesday, August 3, 2011 - 12:17

(FDA: Silver Spring, MD) -- The FDA has announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.

The FDA commissioned the report in September 2009. Although none of the IOM’s recommendations are binding, the FDA is planning a public meeting in the coming weeks to discuss recommendations made in the report, titled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.”

“We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today,” says Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “Medical devices in the United States have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical-device industry in the United States and has helped bring lower-risk devices to market for the patients who need them.

“FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs,” Shuren adds.

In order for a manufacturer to begin marketing a device subject to 510(k) review, FDA must “clear” a premarket notification called a 510(k), demonstrating that the new or modified product is substantially equivalent to another legally marketed “predicate” device.

Some of the IOM’s recommendations, such as the recommendation to design a new regulatory framework for Class II (moderate risk) devices, may require congressional actions. However, the FDA plans to continue its review of the report and to solicit input from stakeholders regarding the recommendations in the report involving existing FDA authorities.

“Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices,” says Shuren. “These actions, plus a sufficiently funded device review program, will contribute to a stronger program. Any major modifications made to the agency’s premarket review programs should be based on sound science and through thoughtful and transparent discussion.”

In September 2009, in response to concerns raised by various stakeholders, the FDA undertook an assessment of its 510(k) program to determine what, if any, changes should be made to improve the program and update it so that it adequately addresses the level of current device complexity and today’s marketplace.

To that end, the FDA committed to an aggressive action plan designed to improve predictability, consistency, and transparency under the existing statutory framework, not only to the 510(k) process but also to its device review programs in general.

For example, the FDA has already:
• Issued a draft guidance clarifying when manufacturer changes to a 510(k)-cleared device already on the market warrant a new 510(k) submission
• Taken several steps under its 515 Program Initiative to address all outstanding “preamendment” Class III device types subject to 510(k) review. The CDRH website includes up-to-date information on the status of each of the 25 remaining device types, and the agency plans to complete this process by the end of 2012.


Still to come:
• Draft guidance to strengthen and streamline the “de novo classification” path to market for novel low- and moderate-risk devices that are not substantially equivalent to an existing device
• Draft 510(k) Paradigm guidance clarifying certain aspects of FDA’s 510(k) substantial equivalence review
• Issue a proposed rule on Unique Device Identifiers (UDI) this fall. The IOM noted that UDI would be a meaningful change to the agency’s postmarket capability.

For more information, see FDA: Medical Devices and CDRH Plan of Action for 510(k) and Science.


About The Author

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The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.