By Daniel R. Matlis

On Monday April 18, 2011, the Medical Device Data Systems (MDDS) final rule becomes effective. Through this rule, the United States Food and Drug Administration (USFDA) classified most Healthcare Information Technology (HIT) Infrastructure as Class I Medical Devices.

Over the last few months, I have had the opportunity to discuss the impact of the MDDS rule with thought-leaders at Healthcare Providers, the FDA, and the HIT Industry.

This article series provides a digest of these interactions with these Industry thought-leaders. In this piece, we will focus on the impact of the MDDS rule on manufacturers of IT systems marketed to Healthcare providers. In our next installment, we will cover the impact of the rule on Hospitals and Healthcare Providers.

The Rule’s Intent

“The intent of the rule is to assure that devices that collect and transfer medical device data that will eventually be used to make clinical decisions are doing so reliably,” said Bakul Patel, Policy Advisor at the Office of the Center Director, Center for Devices and Radiological Health at USFDA.

“I think FDA’s Medical Device Data System rule is a fundamental game changer for Hospitals and Health Information Technology (HIT) vendors,” commented Peter L. Elkin, MD, MACP, FACMI, Professor of Medicine, Vice-Chairman, Department of Internal Medicine and Director, Center for Biomedical Informatics at Mount Sinai School of Medicine in New York.

The Impact on HIT Suppliers

FDA has defined MDDS as a device used to transfer, store, convert or display medical device data.

MDDS devices may include:

  • Off-the-shelf or custom hardware
  • Software products used alone or in combination
  • Electronic or electrical hardware such as a physical communications medium
    • wireless hardware
    • modems
    • interfaces
    • communications protocols

“The advantage for many manufacturers is that it eases the burden and exempts MDDS-type products from premarket review, but they still need to follow the quality standards as for any Class I medical device,” said David Finn, Health IT Officer at Symantec.

“These new FDA requirements would require HIT vendors to follow a rigorous process before they market their products to Healthcare Organizations. MDDS provides an opportunity for each of these individual vendors to kick the tires of their own work and make sure that they are providing the very best offerings that they possibly can to their clients,” said Dr. Elkin.

“Although in general, this new rule eases the burden on many types of medical software, by for example allowing previous Class II or III products to be classified as Class I MDDS, there may be exceptions where previously unclassified products are now becoming regulated,” commented David Finn.

“The regulatory impact of the MDDS final rule will be great, particularly for those Healthcare IT companies that have not adequately prepared themselves for its implementation,” commented Edward J. Johnson Esq., Regulatory Analyst and of counsel for Axendia, Inc. “Perhaps the greatest impact will come in the area of quality systems, where FDA’s expectations of a medical device manufacturer’s quality system and those of an MDDS developer may greatly diverge. Companies that considered themselves software developers or services providers will need to realize they are now considered device manufacturers. Quality activities that had been confined to software development will need to expand their reach into other areas of the company’s operations. They will need to be documented, controlled, monitored and enforced,” he added.

HIT suppliers should begin the MDDS compliance journey by assessing their offerings against these FDA requirements. Suppliers should compile documented evidence of these assessments as well as the rational used to include or exclude specific products from the scope of MDDS rule. Based on the results of their assessment they should develop and implement an action plan to timely meet all applicable FDA regulations.

MDDS Manufacturers must comply with the following FDA requirements: 

  • Register and list their MDDS devices with the FDA
  • Conform to applicable Quality System regulations (21 CFR § part 820
  • Comply with Medical Device Reporting (MDR) requirements (21 CFR § 803)

“Another area of significant impact will come in the areas of Medical Device Reporting,” said Ed Johnson. “MDDS manufacturers will need to put policies, processes and infrastructure in place to address MDR requirements. In some cases, these may just be an extension of the manufacturer’s existing customer service program, but elements such as reporting of deaths or serious injuries may be totally new ground for them. FDA will expect the manufacturer to apply the same rigor to reporting corrections and removals or recalls as to its overall quality system,” he continues.

Final Thoughts

“Clearly, the new MDDS regulation has helped to clarify a lot of the uncertainty around medical software products,” added David Finn. “However, it also includes a great deal of granularity and detail and we advise manufacturers and healthcare providers to seek competent regulatory guidance should questions arise,” he observed.

According to Dr. Elkin, “Healthcare organizations that require these standards be met in their RFAs (Request For Application) for systems, in the absence of regulation, can make safer and more informed choices when purchasing HIT systems and solutions.”

In our next installment, we will cover the impact of the MDDS rule on Hospitals and Healthcare Providers.