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Senator: CDC Wasted Time Early In Pandemic By Insisting On Being Sole COVID-19 Test Developer

 
• By Shawn M. Schmitt

A new report from US Sen. Richard Burr looks at challenges in the country’s public health response to SARS-CoV-2, particularly during the pandemic’s early stages, and recommends ways to better prepare for future pandemics.

Red alarm clock in a waste paper bin.

The US Centers for Disease Control and Prevention (CDC) wasted precious response time in the early days of the COVID-19 pandemic because it insisted on being the only entity to develop a diagnostic to detect SARS-CoV-2.

That’s what a new report from Sen. Richard Burr charges. The North Carolina Republican is a ranking member of...

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UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

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