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Medical Devices

EU Commission Opens Options for Remote Audits for Medical Devices

The Regulatory Affairs Professional Society (RAPS) reports that the Commission of the European Union...

FDA Launches Its Safer Technologies Program for Medical Devices

The U.S. Food and Drug Administration (FDA) has launched a voluntary program to help...

FDA Releases Guidance on EMC of Medical Devices

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

IMDRF Proposes Update on Post-Market Medical Device Studies

The International Medical Device Regulators Forum (IMDRF) has reportedly proposed an update to its...

FDA Seeks Feedback on Premarket Submission Progress Tracker

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based...
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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...

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...

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...
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