Founded in 2008, “October 15 is Global Handwashing Day a global advocacy day dedicated to increasing awareness and understanding about the importance of handwashing with soap as an effective and affordable way to prevent diseases and save lives” (Global Handwashing Day, 2021).

According to the Global Handwashing Day 2021 Fact Sheet (Global Handwashing Day, 2021) just some of the benefits of hand hygiene are:

  • Handwashing can reduce diarrheal diseases by 30%
  • Handwashing can reduce acute respiratory infections by up to 20%
  • Handwashing plays an important role in reducing the transmission of outbreak-related pathogens such as cholera, Ebola, shigellosis, SARS, and hepatitis E
  • Hand hygiene is protective against healthcare-associated infections and reduces the spread of antimicrobial resistance
  • Hand hygiene may contribute to the reduction of Neglected Tropical Diseases

During the pandemic, prior to access of a COVID-19 vaccination, the best way to protect public safety and prevention of transmission of COVID-19 was based on good personal hygiene.  In addition to mask wearing, “individuals should properly wash their hands to prevent direct auto-inoculation” (Litchman, 2020).

While handwashing is always best, if soap and water are not available, the CDC recommends using a hand sanitizer with at least 60% alcohol.  It is important to recognize that, “Alcohol-based hand sanitizers can quickly reduce the number of microbes on hands in some situations, but sanitizers do not eliminate all types of germs” (CDC, 2020).

EMMA International has the regulatory expertise in EUA documentation and submissions and has helped many companies pivot to manufacture hand sanitizers during the pandemic. During the period of the pandemic some of our most popular blogs on the topic included; Health Canada’s COVID-19 Interim Guidance on Hand Sanitizers and Marketing Your Hand Sanitizer During the COVID-19 Pandemic. This week the FDA stated that they will withdraw the temporary guidance for alcohol-based hand sanitizers that were developed to help match the demand for hand sanitizers in the early days of the COVID-19 pandemic effective December 31, 2021 (FDA, 2021). 

EMMA International is here to help any company that stepped up to help during COVID, but now needs help to comply with the new regulatory requirements.

If you are manufacturing under an EUA for any product, check out EMMA International’s Quality Engineer, Gabe Kadoo recent blog, “Preparing for the End of Your EUA”.

EMMA International can help ensure you are compliant so your products can stay on the market to be FDA compliant. Give us a call at 248-987-4497 or email info@emmainternational.com to learn more!


CDC (2020) Handwashing: Clean Hands Save Lives Retrieved from: https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html

FDA (2021) FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers. Retrieved October 13, 2021 from: https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers

Global Handwashing Day (2021) Global Handwashing Day Retrieved October 13, 2021 from:          https://globalhandwashing.org/global-handwashing-day/

Litchman GL, Marson JW, Bhatia N, Berman B. Revisiting Handwashing – As It Is Absolutely Essential. J Drugs Dermatol. 2020 Nov 1;19(11):1127-1129. doi: 10.36849/JDD.2020.5557. PMID: 33196736.

Kira Jabri

Kira Jabri

Kira Jabri, MPH, MSW, PMP is the COO of EMMA International Consulting Group, Inc. She is responsible for designing and implementing EMMA International’s business operations, marketing, and strategy. Mrs. Jabri has over twenty years of experience as a healthcare professional and is an industry expert in company culture and diversity, organizational behavior management, organizational leadership, business strategy development, and contemporary challenges in business. Mrs. Jabri holds a Master of Public Health from Walden University, a Master of Social Work from Columbia University and Bachelor of Arts degrees in Social Work and Psychology from Cedar Crest College.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
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Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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