The United States Food and Drug Administration (FDA), in an attempt to further the safety of the nation’s medical data systems, issued the final rule for the reclassification of medical device data systems (MDDS) on February 15th, 2011 and went into effect on April 18th, 2011. MDDS products are defined by the FDA as products that transfer, store, convert from one format to another format in accordance with a preset specification, or display medical device data which may include software, electronic or electrical hardware, modems, interfaces, and communications protocol (excluding active patient monitoring).[i] Digital-to-analog converters, data systems to record and recall blood pressure, and software to display biological signals are all examples of the type of product affected by this regulation.

Technically, the MDDS products were classified as Class III devices by the FDA, requiring a lengthy and arduous premarket approval (PMA); however, many MDDS manufacturers were unaware of this classification and, as a result, did not enact approval or compliance activities. Until recently, MDDS products were not terribly common and, as such, did not receive much of the FDA's attention. Due to the rapid growth of software and technology in the recent past, the FDA found the need to re-evaluate MDDS products and how the agency intended to control their development and manufacture.

Fortunately for the industry, the FDA eased on their initial proposal written in 2008. While both the initial and final rules call for the reclassification of MDDS products to Class I, the initial rule proposed that those MDDS systems used in a non-professional environment be subject to the increasingly controversial premarket notification [510(k)] system, receiving volumes of recent criticism on its effectiveness. The final rule simply requires companies to register their business and list their products with the FDA (deadline was May 18th, 2011), and to establish a 21 CFR 820 compliant quality system including event reporting (deadline is April 18th, 2012).

What can the medical device industry glean from the implementation of this regulation? Firstly, the final MDDS rule shows that the FDA is open to discussion on newly established or revised regulation. In the end, the FDA determined that listing, registration, and a compliant quality system were enough to ensure that MDDS products were safe and effective. The second and potentially most important impression from this ruling is that the medical device industry voice is powerful and heard by the agency. The feedback that was provided by the industry resulted in the FDA changing the final rule.

The FDA has empowered the medical device industry to provide feedback on its policies, regulations, and rulings which is especially critical considering the volume of regulations and guidance documents scheduled to be released for industry comment in 2011. Industry has recently lauded the FDA’s efforts on how to appropriately regulate mobile applications while equally criticizing the 510(k) process for being over-burdensome and inconsistent. The medical technology industry should approach feedback to the FDA consistent with the Advanced Medical Technology Association’s (AdvaMed) approach. Their coined “Competitive Agenda” seeks a safe and predictable regulatory process that does not hamper medical innovation.[ii] It would be best suited for the medical device industry and the FDA to work together to improve all processes much like what occurred with the MDDS classification ruling changes that occurred between the initial ruling in 2008 and the final ruling in 2011.

Ryan T. Kasun

[i] (2011, April 19). Identifying an MDDS. U.S. Food and Drug Administration. Retrieved July 29th, 2011, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/MedicalDeviceDataSystems/ucm251906.htm

[ii] AdvaMed, (2011, July 28), We need a safe/predictable #regulatory process to support #medtech #innovation and quality care http://bitly.com/iDLSPb #Competitive Agenda [Twitter post]. Retrieved from http://twitter.com/#!/AdvaMedUpdate

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