On August 6, 2013, the FDA issued a federal register notice Modifications to the List of Recognized Standards, Recognition List Number: 032
that recognizes voluntary consensus standards to help support and strengthen the interoperability and cybersecurity of networked and connected medical devices.
Conforming to these standards can help manufacturers meet certain approval or clearance requirements for medical devices related to interoperability and cybersecurity.
There are 25 new standards on medical device interoperability and cybersecurity on List #32, mostly grouped into three categories:
- Eight standards related to managing risk in a connected and networked environment;
- Fourteen foundational standards for interoperability that establish nomenclature, frameworks and medical device specific communications, including system and software lifecycle process;
- Three cybersecurity standards from industrial control systems area that are most relevant to medical devices.
In the past, the FDA has recognized some laboratory information systems standards and imaging standards (DICOM) that relate to interoperability. Medical devices are increasingly connected and interoperability is becoming more important for the safety and effectiveness of medical devices. Therefore, the FDA is working to recognize additional voluntary consensus standards related to the interoperability and cybersecurity of medical devices.
The FDA’s standards program and our recognition of standards enables manufacturers who choose to declare conformity with voluntary consensus standards to meet certain requirements for medical devices. Please visit the FDA recognized consensus standards database
to search for or view the current list of standards.
Thank you for your continued support.
Food and Drug Administration
Center for Devices and Radiological Health