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ALERT: FDA Issues Umbrella EUA for Surgical Masks

Understanding the FDA Requirements to Market Surgical Masks With an Emergency Use Authorization (EUA) During the COVID-19 Pandemic

On August 5, 2020, in response to the COVID-19 pandemic, the U.S. Food & Drug Administration (FDA) issued an umbrella emergency use authorization (EUA) intended to address supply shortages of surgical masks. The FDA has outlined the performance criteria it intends to review as part of EUA submissions and what it expects to be included to demonstrate.

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Have Manufacturing Shutdowns and Delays Spoiled Your Raw Materials

What to Look for When Restarting Manufacturing Operations

COVID-19 has caused serious delays and logistics interruptions for raw material suppliers and component manufacturers.  Manufacturers can help protect product quality and mitigate the risk of financial loss by building sound strategies to assess raw materials, GIPs, and the overall manufacturing process when restarting operations.

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Going Beyond the "Last Mile"

Re-Evaluating Micromobility Vehicles for Changing Usage during COVID-19

Micromobility modals (such as scooters, shared bicycles, and other similar vehicles) were initially designed for multiple, relatively short, trips per day. However, as usage shifts towards longer (and potentially fewer) trips per day, the demands placed on the vehicles will also change. Commensurate modifications to vehicle design and capabilities will be required to meet these new demands.

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Is Your Boiler or Mechanical System Ready for Restart?

Safely Restarting Operations after Extended COVID-19 Shutdowns

Industries across the globe are beginning to restart operations after extended boiler and mechanical system lay-ups amid COVID-19 shutdowns. Because catastrophic boiler explosion, equipment degradation, and further loss of production can occur following a prolonged shutdown, it is important for plant owners and operators to outline detailed restart procedures before bringing boilers and mechanical equipment back online.

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PUBLICATION: Watch: Are Factories Back Up to Speed?

As factories in Asia and around the world resume operations following shutdowns caused by the COVID-19 pandemic, Dr. Ray Huang discusses progress made and obstacles ahead as global manufacturing comes back online. 

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ALERT: In Vitro Diagnostics Regulation Is Going to Replace IVDD in Europe

With No Anticipated COVID-19 Extension for IVDR as with MDR, the Regulation Goes Into Effect in Mid-2022

On May 26, 2020, the In Vitro Diagnostics Directive (IVDD) will cease to govern manufacturers seeking clearance to marketing in the European Union (EU), and instead the In Vitro Diagnostics Regulation (IVDR) will be enacted. 

What are the important implications for In Vitro Diagnostic (IVD) developers from the regulation?

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ALERT: FDA, VA, and NIH Address the Production and Use of 3D Printed Swabs for COVID-19

On May 15, 2020, the FDA, Department of Veterans Affairs' Innovation Ecosystem, and the National Institutes of Health's (NIH's) 3D Print Exchange held a town hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 Public Health Emergency. 

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PUBLICATION: Grain Dust Explosion in a Milling Facility

With facilities currently dormant due to the pandemic, there are several considerations to take before turning industrial equipment back online. 

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ALERT: Trends in Measured PM2.5 Concentrations in the New York City Metropolitan Area During the COVID-19 Pandemic

Concentrations of pollutants, such as NO2 and fine particulate matter (PM2.5) are often related to emissions associated with human activities such as vehicle traffic and industrial activity. As some of these activities have been reduced during the COVID-19 pandemic, associated emissions have likely been reduced. The question considered here is what, if any, changes in PM2.5 concentrations may have occurred during the pandemic in a major metropolitan area?

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ALERT: ASHRAE Issues Guidance on Evaluating Building Systems Before Reopening following COVID-19 Closures

Transmission of Sars-Cov-2 Through the Air Is Sufficiently Likely That Airborne Exposure to the Virus Should Be Controlled

On May 7, 2020, ASHRAE issued a new guidance to assist building owners and decision-makers on how best to reopen their facilities following a closure due to the COVID-19 pandemic. 

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Recovering Manufacturing from a Line Down or Transfer?

Six Key Contributing Factors to Successfully Bringing Up a Manufacturing Line

There are six key contributing factors to successfully bringing up a manufacturing line. These factors, when addressed properly, have helped manufacturers save millions of dollars. 

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Why the Coronavirus Will Continue to Shock Global Markets

Risks That Will Need to Be Quickly Discovered and Corrected by Factories That Are Reopening

The microchip and battery industries have been hit particularly hard, and the effects will continue to delay and stall factories’ ability to resume operations.

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Are Travel Restrictions to China Delaying Your Product Launch Cycle?

In-Region OEM Support in the Era of the Coronavirus

On-the-ground OEM representatives can support design and manufacturing decisions, including the qualification of new suppliers, supplier audits, inventory management, quality control, and reliability test design.

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Force Majeure or Supplier Defect/Contractor Obligation?

Product Supply Chains and Major Construction Projects are Significantly Affected by COVID-19 Outbreak

Reportedly more than 3,000 of force majeure certificates have been issued to Chinese firms since the beginning of February by the China Council for the Promotion of International Trade (CCPIT).

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Supply Chain Diversification During COVID-19

Manufacturing with the ASEAN "Mighty Five"

Manufacturers seeking to expand operations into the "Mighty Five" (MITI-V) nations of Malaysia, India, Indonesia, Vietnam, and Thailand should take steps to understand and mitigate the potential risks associated with diversification into the ASEAN regions.

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PUBLICATION: Consideration of the Aerosol Transmission for COVID‐19 and Public Health

This article analyzes the available evidence to address airborne, aerosol transmission of the SARS‐CoV‐2, reviewing and presenting three lines of evidence. 

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Strategies for Supply Management in China during Travel Restrictions

Leveraging Exponent's Local Presence

With China imposing quarantines on foreigners entering from high-risk countries, just as work at some factories is resuming, it may not be advisable to send domestic staff to manage supply-chain issues.

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ALERT: FDA Issues Temporary Guidance Regarding Non-Invasive Remote Monitoring Devices

Guidance for Industry and Food and Drug Administrative Staff to Support Patient Monitoring During the Coronavirus Disease (COVID-19) Public Health Emergency

The FDA has issued temporary guidance regarding device or software changes that could support remote patient monitoring during the COVID-19 public health emergency.

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Hand Gel Regulatory Requirements

Due to the outbreak of coronavirus in Europe, there is a high demand for human hygiene products in the European market. Before exporting products to Europe, manufacturer should ensure the products are compliant with local regulations and notify/register the products properly.

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ALERT: Trends in Global NO2 Emissions in the First Quarter of 2020

NASA Satellite Data Visualization

Recently, NASA published data on NO2 emissions in the atmosphere over China, Italy and the U.S., in January and February 2020. The "significant decrease" in the February NO2 emissions was "at least partly related to the economic slowdown following the outbreak of coronavirus". 

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Getting Your Head In The Cloud?

Achieving Digital Resilience in the Cloud Era

Organizations that take proactive steps to ensure their cloud-based offerings are robust, scalable, and secure are best positioned to protect employee/customer data and offer a positive user experience during this demand of online services due to COVID-19. 

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US EPA Emerging Viral Pathogens Guidance Trigger

Though the threat level in the U.S. is currently low, the use of disinfectants is an important step toward limiting the spread of the disease. EPA issued this rapid response to provide pesticide registrants with a pathway toward communication to the public.

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A Message from the CEO of Exponent

Catherine Ford Corrigan, Ph.D.
President & CEO

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COVID-19 Test Prep

What Employers Need to Know Before Implementing Employee Screening Programs

Despite rising COVID-19 case numbers in certain areas of the United States, the country is attempting to re-open, and companies are implementing various back-to-work programs. Before implementing a testing program, personnel and health and safety managers need to consider the strengths and weaknesses of the currently available testing for SARS-CoV-2, the pitfalls associated with interpreting test results, and the novel management questions posed by the screening process itself. 

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Is Your COVID-19 Test Ready for At-Home Use?

How Test Developers Can Help Mitigate Risks Associated with OTC Use

As the COVID-19 pandemic continues and communities across the U.S. face difficult decisions over restrictions on schools and businesses, screening will be a critical component in a safe and sustained reopening.By providing data to demonstrate that OTC tests can mitigate these risks, developers of at-home COVID-19 screening tests can strengthen their applications under the FDA’s Emergency Use Authorization (EUA) program, potentially without a prescription-only status.

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Is Your Sterilization Process Putting Your Battery-Powered Devices at Risk?

How Facilities Can Safely Disinfect Handheld Devices During COVID-19

With the rapid spread of COVID-19, many industries are looking for strategies to clean and disinfect shared portable electronics and handheld devices. Of particular concern are shared devices, such as point-of-sale devices or reusable/rechargeable medical devices, whose surfaces may carry the virus into an employee or customer’s personal space. Some of these devices can be disinfected with alcohol wipes, but sometimes more thorough sterilization is required.

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Understanding Non-Compliance During COVID-19

A Human Factors Perspective on Public Health Messaging

Despite the widespread provision of information on how to protect ourselves and restrict the spread of COVID-19, many people ignore the latest recommendations and local ordinances by gathering in large groups, crowding public spaces, and failing to wear face coverings in public. While such behaviors may arise out of necessity, why would individuals otherwise choose to act in ways that disregard official and unofficial health advice?

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Infrared Thermometry Amid the COVID-19 Pandemic

Knowing the Limitations to Ensure Accuracy for Effective Screening Programs

Hand-held non-contact infrared (IR) forehead thermometers have become increasingly popular tools for measuring body temperature as part of COVID-19 related mitigation measures, due to their rapid, non-invasive, and hygienic approach to thermometry. Yet the limitations of non-contact IR thermometers are often not properly understood by those seeking to design and implement appropriate fever screening procedures. 

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Keeping It Clean: Responding to Increased Demand for Hand Sanitizers

Product Compliance During and After the Pandemic

As the COVID-19 pandemic has increased the demand for hand sanitizer, many health authorities around the globe have temporarily modified regulatory requirements specific to hand sanitizers. This creates the opportunity for new manufacturers to to enter this market in both the near and long term. How will the regulation modifications affect the new and current manufacturers producing ingredients for or formulating final hand sanitizer products? 

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ALERT:Substantial Decreases in Measured Air Pollution Concentrations in the New York City Metropolitan

Trends During the COVID-19 Pandemic

Concentrations of PM2.5 and other criteria pollutants, such as nitrogen dioxide (NO2), ozone (O3), and carbon monoxide (CO), are often related to emissions associated with human activities, such as vehicle traffic and industrial activity.  The question considered here is whether measurable changes in criteria pollutant concentrations may have occurred in the New York City metropolitan area during the pandemic.

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PUBLICATION: Textiles & The Coronavirus (SARS-CoV-2)

Understanding the regulations and critical characteristics of personal protective equipment (PPE)

During the COVID-19 pandemic, personal protective equipment, or PPE, has entered the common vernacular- but did you know that PPE has specific regulatory definitions and requirements? 

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ALERT: Emergency Preparedness Planning

Post-Market Surveillance and Adverse Event Reporting for Medical Products during a Pandemic

The COVID-19 pandemic has disrupted many healthcare-related businesses in unanticipated ways. As a result, there is substantial focus on developing emergency contingency procedures for essential processes, including post-market surveillance and adverse event reporting.

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ALERT: Sewage Sleuthing

What Waste Can Tell Us About Upstream Events, Including Coronavirus?

Genetic methods are increasingly being researched and applied to monitor sewage for SARS-CoV-2—the novel coronavirus that causes COVID-19. Exponent teams have used these tools in the field and understand their advantages and disadvantages, as well as procedures for their successful deployment to characterize bacterial populations, antibiotic resistance, viruses, fecal indicators, and chemicals in wastewater and the environment.

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ALERT: New Policy for Non-Invasive Fetal and Maternal Monitoring Devices During COVID-19

On April 23, 2020, The U.S. Food and Drug Administration (FDA) issued guidance to expand the availability and capability of non-invasive fetal and maternal monitoring devices designed to measure or detect fetal heart rate, maternal heart rate, or uterine activity. The enforcement policy  allows for modified use of devices previously only employed in a clinical setting to facilitate patient monitoring at home and increase access to important prenatal data while also reducing patient-provider contact during the COVID-19 pandemic.

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ALERT: Incident Investigations Locked Down

Collecting and Preserving Evidence from Fires and Explosions During COVID-19

As valuable evidence from fires and explosions deteriorates over time, making it important to document the scene and preserve physical evidence soon after the incident. Exponent is uniquely positioned to investigate fires and explosions before the loss of potentially important physical evidence while following local and state-specific orders and health and safety guidance.

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Are You Purchasing Low-Quality Face Masks?

Tips for Importing Face Masks During COVID-19

To protect the safety of healthcare professionals and other occupational mask wearers, importers should perform comparative assessments of commercial masks before purchase. If possible, importers should also evaluate mask options to ensure they meet quality requirements for occupational use. 

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ALERT:Supply Shortages Spark New Concerns as the FDA Receives Record Numbers of In Vitro Diagnostic EUA Applications

Developers Bring Concerns Over Shortages in Reagents and Swabs to Light, but Pooling Is Not Always the Answer

On July 1, 2020, the FDA held its weekly town hall-style meeting. Due to shortages in reagents, attention is turning to sample pooling. A spike in MedWatch complaints has alerted the FDA that a popular platform's reagent

Since March 16th, the FDA has been holding town-hall style meetings for the in vitro diagnostics (IVD) community.

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ALERT: FDA Issues Temporary Guidance for Face Masks and Respirators

Guidance for Industry and Food and Drug Administration Staff During the Coronavirus Disease (COVID-19) Public Health Emergency

The FDA has issued temporary guidance regarding enforcement policies for face masks and respirators during the COVID-19 public health emergency to clarify the regulatory landscape and help expand the availability of these products. 

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ALERT: Continuing the Trend of Lower Carbon Emissions in a Post COVID-19 World

On April 30, 2020, the International Energy Agency released a report predicting that the effects of the ongoing COVID 19 pandemic will result in reduced carbon dioxide (CO2) emissions globally by nearly 8% in 2020 compared to 2019. However, the effects of the COVID 19 pandemic could be short-lived, with the report predicting that emissions will return to normal levels as the impacts from COVID-19 dissipate.

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Managing Manufacturing Disruptions During COVID-19

Mitigating Risks Associated with Process Tuning and Raw Material Substitution

While process tuning and material substitutions can help suppliers accelerate production or cut costs, extra attention should be paid when implementing these changes concurrently with what will likely be one of the largest global manufacturing ramp-ups in recent history. 

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FDA Temporary Policy for Preparation of Certain Alcohol-based Hand Sanitizers

On March 19, 2020, the U.S. Food and Drug Administration (FDA) issued a bulletin entitled “Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry.”

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Connect with our Team

Looking to speak with an Expert?

Ellen P Donovan, MPH
Director, Business Development
(650) 688-6940

If you are looking for a specific consultant, their contact information can be found by searching our Professionals page.