A front-page article in today’s New York Times reporting on Coronavirus mentions a harrowing experience that Italian doctors face in Northern Italy. Caught in one of the pandemic’s worst spots, due to insufficient resources, medical professionals are having to triage critical care. They are deciding who gets treatment and a chance to live, and who doesn’t and therefore are left by society to die. Thus in the 21st Century, with all its modern wonders, ailing elderly in a civilized nation are triaged out of existence.
Why and How Is Coronavirus Causing a Health Care Crisis?
The story is a sober reminder that worst-case scenarios are not the primary focus of health care system designs. Systems designed to accommodate worst-case scenarios would have a real potential to deny resources to those who pose comparably higher risk to the healthy population. The solution presented by most systems in address of a pandemic is to “flatten the curve” — to retard the spread of infection, by aggressive treatment of the earliest presented cases, in order to lower the aggregate risk to the general population. Left unmitigated, pandemics spread quickly through a population. Successful retardation of that spread, however, stretches it out–or flattens the curve–so a health care system can continue to treat the sickest at successive stages of the health crisis.
What the U.S. Is Doing About Coronavirus
The United States is learning — or, at least, hopes to do so — from mistakes made in Italy. With remarkable swiftness, virtually all sports activity schedules were affected nationwide for an indefinite period of time, as we cannot accurately predict the duration of the Coronavirus pandemic. Effectively, this results in cancellation or indefinite postponement of an entire season of major spectator events:
- The NCAA Division I Men’s Basketball Tournament, known as “March Madness”
- The Masters Tournament for professional golf
- NBA games
- College sports
- Professional soccer matches
Also affected are other venues of mass gatherings:
- Music concerts
- Business conventions
- Theme parks (Disney, Universal, Six Flags)
- Broadway shows
- Resort-property entertainment and dining
We have entered The Twilight Zone, life imitating art. Maintain distance, avoid crowds, and keep food and other essentials stocked in refrigerators and back bedrooms. Work from home if possible. Stay safe. Don’t catch or spread disease. Ride it out, safely.
How the Supply Chain Is Reacting to the Coronavirus Pandemic
Meanwhile, we at FDA 510k Consultants are still in business, and are doing what we can to help the world improve community health. In recent weeks we have held talks with new players interested to bring to market desperately needed face masks for a worried citizenry at serious risk of impact by Coronavirus. Though we are a small business, we are an important piece of the global supply chain’s reaction to recent demand and supply shocks. Our business partners continue to report stronger demand for product clearance as the pandemic spreads. Meanwhile, as authorities gain effective control over Coronavirus in China, our sources there say that their factories have been released to recommence sales and production for other markets at risk, such as the United States. Of course, that is good news for everybody.
How Face Masks Are Regulated in the United States
Since most of our calls about Coronavirus are for face masks, we want to pass along the steps required to receive FDA’s “approval” for these products.
Face masks are a unique product, with respect to the United States medical regulatory regime, which in this case involves two agencies of the Department of Health & Human Services (HHS). The Food and Drug Administration (FDA), which clears Surgical Masks, shares regulatory oversight with the Centers for Disease Control and Prevention (CDC), which certify Surgical/Particulate Respirators through the National Institute of Occupational Safety and Health (NIOSH). (Both the CDC and the NIOSH are arms of the FDA.)
Your typical, three-layer, disposable face masks sold through America’s major retail outlets — namely, general retail outlets (e.g. Walmart), pharmacy-anchored specialty stores (e.g. CVS and Walgreens), and internet storefronts (e.g. Amazon) — are “surgical masks” as classified by FDA, and carry the same regulatory burdens as the masks marketed to hospitals, doctors, and other health care providers. They are designed to protect both the wearer and others from contamination by large droplets of sweat, blood, and so forth.
In contrast, FDA assigns different classification to “surgical respirators,” a definition which includes N95 Respirators and a variety of thicker disposable masks which create comparably greater difficulty for human respiration. They are designed to protect the wearer against airborne particles like dust and viruses. In an airborne pandemic like COVID-19 — the official name of the Coronavirus disease originating sometime in autumn 2019, in Wuhan, China — you want to stock a respirator at work or home.
More technically, FDA requires clearance of Surgical Masks through the filing of a 510(k) Premarket Notification (Regulation 21 CFR 878.4040, Product Code FXX). Meanwhile, FDA allows NIOSH certification for Surgical (or Particulate) Respirators (878.4040, MSH).
What Tests Are Required by FDA
Getting a little deep into the weeds, both types of masks require the same testing: Biocompatibility (ISO 10993-1) for cytotoxicity, sensitization, and irritation; and Performance (ASTM F21000) for particulate filtration efficiency, fluid resistance, bacterial filtration efficiency, differential pressure, and flammability.
Other Things That FDA Requires
In addition to 510(k) clearance for Surgical Masks or NIOSH Certification of N95 Particulate Respirators, FDA’s immediate requirements before going to market are:
- Registration of the manufacturer and (if applicable) initial importer (this year’s fee is $5,236, for each establishment); and
- Listing of the mask device.
How Cheap Masks Are Entering the United States
The cheap, disposable masks sold online are being sold illegally (and, incidentally, have caused Amazon’s recent crackdown on sale of disposable masks). By that we mean they do not have either 510(k) Clearance or NIOSH Certification.
To determine how these products are getting through customs, we tracked one supplier back to FDA’s registration & listing database. The masks were listed as Scavenging Masks (868.5590, KHA). Such devices are exempt from 510(k) clearance, which explains how they cleared customs. But their intended use is not as a medical mask, and therefore cannot legally be sold as surgical masks or respirators.
The legal pathway to market for these medical masks is, therefore, complicated — and we are prepared to help you through it.
What the Future Holds for Global Communities
To put the current pandemic in perspective, consider two points of interest.
First, serious viral outbreaks in recent years include:
- 1997 Bird Flu
- 2003 SARS Coronavirus
- 2009 H1N1 Swine Flu
- 2012 MERS Coronavirus
- 2013 H7N9 Bird Flu; and
- 2020 COVID-19 Coronavirus.
The point, of course, is that more are coming. It’s time the world began preparing for more pandemics.
The second point is that on average influenza strikes 30 million Americans and kills 30 thousand every year. Yet we don’t shut down society every winter and spring. What’s different about COVID-19 is a higher degree of uncertainty — just too many unknowns. Once we understand the virus better, we’ll calm down and handle future outbreaks better. Fortunately, we will have at lest one residual benefit: some new immunity to influenza-like infection.
What Our Company Does for You
FDA 510(k) Consultants, as our name implies, specializes in the registration, listing, testing, and 510(k) clearance of all types of medical devices, including face masks. We focus on U.S. device regulatory compliance, so we pretty much know how to do anything required by FDA for medical device entrance into the American market.
If you want help clearing a new device, call or e-mail us for a 30-minute consult. Pick our brains for free!