Continua Statement Re: FDA Recognition of Medical Device Standards for Interoperability

This week, the US Food and Drug Administration (FDA), Department of Health and Human Services (HHS), published a list of recognized standards for interoperability intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

A total of 25 standards on medical device interoperability and cyber security are recognized, including the standards that underlie Continua's Design Guidelines for end-to-end, plug-and-play connectivity of medical devices, systems and services in personal connected health. This is a significant step forward for interoperability and an important recognition of Continua's relevance in the market.

FDA's recognized standards can be categorized into 3 groups:

  • Risk management standards for a connected and networked environment;
  • Interoperability standards that establish nomenclature, frameworks and medical device specific communications and including system and software lifecycle processes;
  • Cyber security standards from the industrial control area most relevant to medical devices.

You can view the official publication here:

In an email promoting this landmark announcement, Bakul Patel, Senior Policy Advisor to the Director of the Center for Devices and Radiological Health (CDRH) at FDA, noted:

"As we as a community continue on the journey of interoperability, we recognize that not only working collaboratively with stake holders (such as you) is a must, we at FDA must also enable such collaboration while taking a proactive step towards promotion of safe interoperable solutions."

Federal initiatives to address interoperability standards in healthcare are among the more sweeping changes we have seen since Continua was founded in 2006, including activity in the United States, UK, Denmark, Singapore, Japan, and the United Arab Emirates. Please join us in congratulating the FDA for taking these measures, and thank you for your continued support.

Chuck Parker

Executive Director

Continua Health Alliance

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