The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA news release.
The rule classifies these products, known as medical device data systems, as Class I or low-risk devices, making them exempt from pre-market review but still subject to quality standards. MDDS 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 pre-market 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 pre-market notification and applying the level of regulation reserved for low risk devices.
However, manufacturers must comply with all Class I requirements, including registering with the FDA, listing their MDDS products, reporting adverse events and complying with the FDA's Quality Systems regulation.
Read the FDA news release about its final rule on medical device soft- and hardware.
Read other coverage about the FDA:
- Study: Recalled Medical Devices Were Cleared Through Less-Stringent 510(k) Process
- FDA Draft Guidance: Recommended Warning for Surgeon's and Patient Examination Gloves That Use Powder
- FDA Awards Contract to Develop Sentinel System Pilot for Evaluating Medical Product Safety
The rule classifies these products, known as medical device data systems, as Class I or low-risk devices, making them exempt from pre-market review but still subject to quality standards. MDDS 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 pre-market 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 pre-market notification and applying the level of regulation reserved for low risk devices.
However, manufacturers must comply with all Class I requirements, including registering with the FDA, listing their MDDS products, reporting adverse events and complying with the FDA's Quality Systems regulation.
Read the FDA news release about its final rule on medical device soft- and hardware.
Read other coverage about the FDA:
- Study: Recalled Medical Devices Were Cleared Through Less-Stringent 510(k) Process
- FDA Draft Guidance: Recommended Warning for Surgeon's and Patient Examination Gloves That Use Powder
- FDA Awards Contract to Develop Sentinel System Pilot for Evaluating Medical Product Safety