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FDA warns over use of robotically-assisted surgical devices

Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of...

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After a long and winding road, FDA finalizes much-debated “intended use” rule

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...

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On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when...

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Domestic sourcing guidance issued to help American businesses compete

Last week, the White House Office of Management and Budget issued guidance to federal agencies implementing a January executive order that aimed to strengthen American industry through...

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First company receives FDA violation notice for ClinicalTrials.gov submission omission

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results...

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HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical ...

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FDA issues new policy for evaluating impact of viral mutations on COVID-19 tests

The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The...

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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 ...

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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...

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