What is the MDDS Rule?
In April, 2011, the FDA finalized and announced a final rule providing 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. Basically MDDS’s are passive databases or communications software products.
Specifically these software programs take data from a medical device and display, transfer, store, or convert that data from one format to another according to pre-set specifications. The software cannot change the function or parameters of any connected device.
The FDA indicated that any provider of an MDDS must register with the FDA by May 16, 2011.
An MDDS is a software program that takes data from a medical device and displays, transfers, stores, or converts that data from one format to another. It cannot change the function or parameters of the connected device.
To learn more about the MDDS announcement, visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm243283.htm.
Software used to create electronic Patient Care Reports (PCRs), which is widely used through the EMS community, was impacted by this FDA ruling. Clearly this category of software, including RescueNet ePCR software, provides a mechanism for transferring, storing, converting, or displaying medical device data.
The regulatory team at ZOLL has had detailed discussions with the FDA to get further clarification. The FDA affirmed that ePCR software does not meet the definition of an MDDS but instead is a Class II device and consequently requires 510(k) clearance for commercial distribution. Specifically the FDA documentation included the following specific definition:
An MDDS is defined as “. . . a device that is intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. An MDDS acts only as the mechanism by which medical device data can be transferred, stored, converted, or displayed. An MDDS does not modify the data or modify the display of the data. . . Any product that is intended for a use beyond the uses (or functions) identified in this final Classification rule is not an MDDS and is not addressed by this rule.”
The functionality offered by most commercial ePCR systems used extensively by EMS personnel, provides both the “. . . mechanism by which medical device data can be transferred, stored, converted, or displayed,” and they “. . . modify the data or modify the display of the data.” Clearly, these ePCR systems are “. . . intended for a use beyond the uses (or functions) identified in this final Classification and are not an MDDS and are not addressed by this rule.” Visit here to read the actual FDA MDDS regulation.
In addition to taking data from a medical device and displaying, transferring, storing, or converting that data from one format to another, a Class II medical device also allows for the modification of the data or the display of the data.
In ongoing conversations with the FDA, the ZOLL regulatory team asked for further clarification on the differences between an MDDS and a Class II device. Additionally we asked for verification of ZOLL’s assertion that RescueNet ePCR software is not simply an MDDS and should have 510(k) clearance as a Class II medical device.
The FDA agreed with ZOLL, stating in writing, “. . . you stated that since your device allows manual entry of the data, it is not considered an MDDS. The agency agrees with your assessment.”
The FDA ruling clearly states that a device classified as an MDDS does not require 510(k) clearance. However, based on the interpretation by both ZOLL and the FDA, RescueNet ePCR is clearly a Class II medical device and is subject to 510(k) clearance. Consequently, ZOLL applied for and received clearance as a Class II medical device. Our 510(k) number is K103473.
The highest quality development and testing standards and processes have always been a key component of all ZOLL products. Prior to the announcement by the FDA, ZOLL employed personnel dedicated to defining product requirements and creating test plans. FDA clearance involved a review of these existing quality assurance test plans to ensure that ZOLL followed well-defined and proven processes and procedures.
Compliance with this FDA regulation did not require ZOLL to add any personnel or distract resources from normal development activities. The vast majority of documentation that ZOLL submitted to the FDA as part of the clearance process was already in place as part of the existing test and quality processes at ZOLL. As new releases and service packs are made available, they will not require review and clearance by the FDA unless major changes are made to the software. ZOLL’s product roadmap will not be slowed by the change in FDA requirements.
If you have chosen RescueNet ePCR software, you know that you are selecting a resource with the highest quality development and testing standards proven and already in place. We don’t specifically know how the FDA will react as other PCR software vendors with more limited resources begin to navigate the FDA requirements.
We are encouraged that the majority of organizations developing commercial ePCR software have taken the preliminary step of acknowledging the FDA ruling and registering as a Class I MDDS. However, we believe that companies have not correctly interpreted the FDA ruling and that they should only be selling and distributing ePCR software after receiving 510(k) clearance from the FDA. We strongly encourage you to consider this situation as you go through your evaluation and selection process for a potential ePCR provider.
With ZOLL, you have an ePCR solution that you can depend on.
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