Regulators Ease Controls On PPE Manufacturing

The U.S. Department of Health and Human Services has said that to battle a respiratory pandemic for one year, the U.S. will need 3.5 billion N95 respirators. The Strategic National Stockpile holds only 12 million N95 respirators and 20 million surgical masks. Identifying the vital need among the medical community, first responders and others, businesses of every stripe have been reorienting to provide the necessary personal protective equipment.

As the world increases its production of medical masks, respirators, gloves and gowns, the risk of counterfeit and fraudulent products is likely to increase. The Wall Street Journal reports that more than 100 masks and regulators listed online were either counterfeit or had unverifiable claims. Business Insider says that China pulled 31 million counterfeit N95 masks from store shelves. Government agencies have warned that businesses caught selling these goods, even unknowingly, could be liable for criminal or civil penalties. And there’s also the damaging hit to their reputations to consider.

Fortunately, authorities around the world have eased regulations to help supply match demand as typically it would take months for these products to enter the market. Medical devices are generally categorized in a risk-based classification system. PPE typically falls under Class 1 and Class 2, defined by a lower risk and simple design, and by medium risk and more complex design, respectively. Class 2 medical devices also have specialty regulatory controls. In the U.S., the FDA has dropped the 501(k) premarket notification, which requires that new medical devices in both categories demonstrate that they are cleared as “substantially equivalent” to a predicate device in terms of intended use, technological characteristics and performance testing, as needed.

Regulatory authorities have taken other steps to ease regulations and increase supply of masks and regulators. These steps are temporary in nature, lasting until the COVID-19 crisis abates, and apply to PPE for health-care workers and frontline responders and not intended for general commerce or consumer distribution. Along with decreasing the level of requirements for gloves, gowns and facemasks, the FDA does not intend to object to the distribution and use of face masks—not including respirators—that are intended for a medical purpose—whether used by medical personnel or the general public—without compliance to a series of typical regulatory requirements. Facemasks must not create an undue risk, however. The FDA has also expanded the range of respirators that can be imported into the U.S. from a select group of countries.

Testing and certification firm SGS recently hosted a webinar on disposable medical PPE and what businesses need to know when moving into the space. Click here for a recording of the webinar.

filed under April 2020
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