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“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when...

News

The European Commission issues guidance concerning management of legacy devices in EUDAMED

On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices ...

News

Biden Issues wide-ranging Buy American Executive Order – FAR rulemaking to come

On 25 January 2021, President Biden issued his first Buy American Executive Order (EO), titled Ensuring the Future Is Made in All of America by All of America’s Workers, which is...

News

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations...

Insights

UK regulation of medical devices from 1 January 2021
Registered Content

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ...

News

COVID-19 Report for Life Sciences and Health Care Companies (21 - 24 September 2020)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

News

COVID-19 Report for Life Sciences and Health Care Companies (14 - 18 September 2020)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

News

COVID-19 Report for Life Sciences and Health Care Companies (7 - 11 September 2020)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

News

COVID-19 Report for Life Sciences and Health Care Companies (1 - 4 September 2020)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

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