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FDA Finalizes Regulation for Certain Software, Hardware Used With Medical Devices

Mon, 02/14/2011 - 10:30am
U.S. Food & Drug Administration

For Immediate Release: Feb. 14, 2011

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA finalizes regulation for certain software, hardware used with medical devices

Rule provides more predictable path to market

Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

“This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems,” said Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health. “This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers but continue to assure that data stored, transferred or displayed on these systems remain reliable.”

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification.

Examples of MDDS products include: devices that collect and store data from a glucose meter for future use or that transfer lab results to be displayed at a nursing station for future use.

Prior to this rule, first proposed in 2008, FDA considered these devices to be either Class III (or high-risk) devices requiring premarket approval or accessories to an existing medical device.

By down-classifying these devices into Class I, the FDA is exempting all manufacturers of MDDS from premarket notification and applying the level of regulation reserved for low risk devices. Moreover, these manufacturers must comply with all Class I requirements including registering with the FDA, listing their MDDS products, reporting adverse events and complying with FDA’s Quality Systems regulation, a  basic system of manufacturing and design controls that, among other things, will ensure manufacturers test their products before marketing them.

The rule also levels the playing field for medical device manufacturers. Information technology companies that design, install or market these systems, and hospitals that develop them in their facilities, must follow Class I requirements as well.

The Medical Device Data Systems rule will be published in the Federal Register tomorrow and is available for advanced viewing today.

For more information

Medical Device Data Systems

 

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