Standards by Topic

The Commission of the European Union (EU) has issued its requirements for the medical...

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently...

EU Task Force Offers Clarification of Surveillance Requirements for Legacy Medical Devices

A European Union (EU) task force has issued a document intended to clarify the...

FDA Offers Best Practices for Alerting About Cyberthreats

As concerns about cybersecurity become part of the everyday threat landscape, the U.S. Food...

FDA Issues Draft Guidance on 510(k) Electronic Submission Template

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further...

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FDA Publishes List of Approved AI/ML-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) has published its first list of authorized...

UK Seeks Overhaul of AI, Software as a Medical Device

In the wake of its exit from the European Union, the United Kingdom is...

EU Commission Updates List of Harmonized Standards for MDR

The Commission of the European Union (EU) has updated its list of harmonized standards...

FDA Offers Online Tracker for Premarket Submissions

The U.S. Food and Drug Administration (FDA) now has a secure web-based tracking system...

Toward Standardization of Low Impedance Contact CDM

The 16.6 ohm implementation of contact CDM (LICCDM) recently published in ANSI-ESD Standard Practice 5.3.3 is shown to produce waveforms of similar shape, I_fail, and I_peak vs. C_eff dependency as JS-002. The non-monotonicity of JS-002 at low voltages is overcome using LICCDM. A path to joint standardization with air discharge testing is proposed.

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