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Standards by Topic

FDA Issues Guidance on ISO 10993-1 for Medical Device Biological Evaluation

The U.S. Food and Drug Administration (FDA) has issued a guidance document on the...

FDA Issues Guidance on Recognition of Voluntary Consensus Standards

The U.S. Food and Drug Administration (FDA) has issued a guidance on how the...

Why Resistance Requirements Differ by Industry and Why Standards Matter

Confusion over ESD flooring resistance terminology and requirements abounds, leaving many in the dark and creating potential risks. This article helps to clarify this complicated issue so that you can work to mitigate the problem.

FDA Clarifies Registration, Listing Requirements for Medical Device Manufacturing Facilities During Pandemic

The U.S. Food and Drug Administration (FDA) has provided updated clarification on its requirements...

EU Commission Issues Regulation Regarding Single-Use Medical Devices

The Commission of the European Union (EU) has issued common specifications for the reprocessing...
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Australian Radio Communications, EMC and EMF Regulatory Requirements: A Primer

Wireless devices are now in the legislative spotlight the world over. Safety, performance, spectrum usage and protection of personal data are all matters of regulation, although countries vary in how they regulate such concerns. This article looks at Australia as a case study, reviewing the overarching legal framework, the role of the national regulator, conformity assessment and the use of standards.

U.S. FCC Grants Healthcare Waiver to Expedite Medical Equipment

In the midst of the COVID-19 pandemic, the U.S. Federal Communications Commission (FCC) has...

EUs MDR Date of Application Delayed Until 2021

In a major development for medical device manufacturers, the Parliament and Council of the European...

U.S. FDA Temporarily Eases Enforcement Policies for Certain Digital Health Devices

Moving quickly to address the need for advanced medical technologies during the COVID-19 outbreak...

FDA Updates Database of Recognized Consensus Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized standards...
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