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© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
BY Manuel Garza, Principal Consultant - 4.1.20 -
In summary
FDA is moving quickly to implement emergency use applications (EUAs) policy to provide flexibility to those manufacturers of face masks and respirators to meet the need of medical practitioners and consumer demands.
The COVID-19 pandemic has seriously impacted our healthcare system and the demand for face masks and respirators has overrun the capacity of the domestic and global manufacturing capacity and has placed patients and the medical community at risk. There is an immediate need and demand for face masks and respirators that can be easily and reliably deployed. Recently in the virtual, printed and televised press, numerous companies have been augmenting their production processes and product workstreams to produce face masks and respirators. The manufacturers vary from medical device companies to companies not in the medical field retooling and converting to manufacture these required face masks and respirators.
The challenge for these manufacturers is their varied and diverse nature, their facility controls, and their capabilities to consistently produce a product intended for medical purposes while not creating an undue risk in light of the public health emergency. This was likely the impetus for the FDA to create and implement an enforcement policy for face masks and respirators without a commentary period.
The following talking points provide a high-level synopsis of the enforcement policy intended to remain in effect only for the duration of the public health emergency:
Enforcement Policy for Face Masks and Respirators During the COVID-19 Public Health Emergency - March 2020
Face Masks and N95 Respirators Not Intended for a Medical Purpose
Face Masks Intended for a Medical Purpose that are NOT Intended to Provide Liquid Barrier Protection
Surgical Masks Intended to Provide Liquid Barrier Protection
FDA’s Intended Approach for EUAs for Masks and Respirators
The challenge for these manufacturers is their varied and diverse nature, their facility controls, and their capabilities to consistently produce a product intended for medical purposes while not creating an undue risk in light of the public health emergency. This was likely the impetus for the FDA to create and implement an enforcement policy for face masks and respirators without a commentary period.
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