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medical devices

FDA Issues Guidance Documents on Pilot Accreditation Scheme

The U.S. Food and Drug Administration (FDA) has issued three final guidance documents in...

FDA Seeks Feedback on Premarket Submission Progress Tracker

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

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...
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EU Commission Issues Regulation Regarding Single-Use Medical Devices

The Commission of the European Union (EU) has issued common specifications for the reprocessing...

FDA Issues Initial Guidance on Medical Device Regulatory Submissions in Electronic Format

The U.S. Food and Drug Administration (FDA) has issued initial guidance on its general...

EU Commission Releases Report on Notified Body Response to Medical Device Conformity Assessments During Pandemic

The Commission of the European Union (EU) has published the results of its survey...

U.S. FDA Issued Guidance on Enforcement of Non-Invasive Remote Monitoring Devices

As the impact of the COVID-19 pandemic continues to challenge the nation’s healthcare system,...

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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