FDA Regulatory and Clinical Services for the Medical Technology Industry

Press Release

M Squared Associates Providing Pro Bono Consulting Services to Expedite COVID-19 Related FDA Applications for Critical Medical Supplies

NEW YORK, April 8, 2020 /PRNewswire/ -- COVID-19 has profoundly impacted all of us. Health care providers on the front lines of caring for infected patients are facing critical shortages of basic necessities such as personal protective equipment (disposable face masks and N95/KN95 respirators, face shields and safety goggles, single use gowns and gloves) and kits for diagnostic test samples, as well as more sophisticated medical devices such as ventilators and monitoring equipment. FDA has declared the COVID-19 outbreak a public health emergency and implemented an expedited pathway to market authorization for products crucial in addressing this crisis, the Emergency Use Authorization (EUA). The EUA pathway gives FDA authority to authorize rapid access to unapproved medical devices and diagnostic tests (or unapproved uses of approved devices) for emergency applications where there are no adequate or approved alternatives available.

New York City based M Squared Associates (M2), a consulting firm providing regulatory, quality and clinical services to the medical technology industry, has been providing pro bono consulting expertise to innovators and developers who may not be registered medical device manufacturers, but who can help address shortages of supplies needed for the diagnosis, treatment, monitoring and prevention of COVID-19 in the US and globally. M Squared Associates is helping to determine eligibility for the EUA program, assess if a specific product meets the definition of a medical device, and prepare documentation for submission to FDA (or another regulatory body) prior to manufacturing and distribution. The company is also assisting manufacturers who are reconfiguring their facilities in an effort to help alleviate supply shortages, helping navigate key submission criteria for obtaining a successful EUA designation and compliance with conditions of an approval.

Nick Jungbluth, MPH, Director of Business Development, commented, "We recognized that our skill set offers a unique opportunity to make an immediate impact, given M Squared's specialized expertise in helping companies assess medical device technology and quickly get to market. Pro bono partnerships with device manufacturers is one way M2 can assist in mobilizing the dedication, entrepreneurial spirit and resilience we're seeing from companies in response to the COVID-19 pandemic."

For more information about M Squared Associates please visit www.msquaredassociates.com.

Media Contact:
Nick Jungbluth
347-536-4640
COVID19@msquaredassociates.com