FDA Certificates Don’t Mean Anything

With the current pandemic, face masks have become and everyday necessity.

Many factories and manufacturing companies that produce other things, have jumped in to help with the fulfilling of coronavirus demands. From breweries making hand sanitizer, to GAP Inc., that usually makes clothes, switching to making face masks.

Shenzhen Newstar Optical Electronic Technology in China was a company that did this exact thing. They usually are producing LED displays, but took on an order to make 100,000 masks.

Unfortunately, the company that requested the masks did not get what they needed. According to NPR Pharmaceuticals correspondent, Sydney Lupkin, the ordering company received masks that were not usable. They masks were dirty, stained, and covered in dust.

When the complainant started asking questions about the faulty masks, the only thing they received was an FDA certificate of registrations. However, with the problem occurring in March, the certificate was dated “April 7, 2020”.

Many factories, especially those in China, have began using FDA certificates to promote themselves as trustworthy producers of face masks. These certificates tend to come with the FDA logo and an eagle printed on them.

These certificates do not mean a thing.

Yes, the FDA does require manufacturers of medical supplies to be registered, this is only so that the administration can keep track of them. Certificates are not something given to registered companies.

Although companies wishing to sell medical devices in the United States are required to register with the FDA, this does not mean much. The manufacturers being registered does not mean that they have met any kind of quality standard.

As an example, Shenzhen Newstar Optical Electronic Technology is legitimately registered with the FDA. However, the FDA has never given them clearance for medical devices. They haven’t even been inspected for the production of medical devices.

According to Benjamin England, a consultant and attorney based in Maryland, a lot of companies that were making teddy bears, hats, and socks just last week, have started making masks.

An NPR analysis states that more than 50% of surgical masks that were imported between March and July earlier this year, were from China or South Korea. These shipments came from separate logistics companies making them pretty much impossible to tell which companies actually manufactured them.

The problem with this is that these countries expect to receive such a certificate. To satisfy this expectation, the people helping the companies register in the U.S. just create one themselves.

The administration has even stated in an FAQ that they do not give any companies this kind of certificate. Meaning that they cannot guarantee the manufacturer is regulated by their requirements.

With this, one thing does need to be clarified.

Regular operating procedures do require surgical masks meet certain FDA clearance. However, due to the pandemic, the agency has decided to waive such clearances to help fill the need for such masks.

With these unregulated procedures, many places in the medical community have received masks that break and wear out before their employees get through a shift. Often the materials used also affect the wearers skin, causing it chap and break out.
In response to the lack of quality protective equipment, many people use alternatives instead.

Employees that work in different areas of retirement living communities are often given masks made by residents that work better and are made with a higher quality.

Source: NPR

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