The coronavirus pandemic that began in late 2019 in Wuhan, China, triggered an unprecedented, global surge in demand for personal protective equipment (PPE). This “demand shock” quickly overwhelmed the world’s supply chain for face masks, N95 respirators, infrared thermometers, ventilators, and other disease-protective apparel. In a strange-but-true twist, the vast majority of this protective gear is manufactured in China. So while the problem traces back to that country, so does a critical component of the solution.
FDA’s system for regulating the safety and effectiveness of PPE, as is true for most medical devices, works well if one is not in a hurry. But today the United States is in a hurry—in fact, a very big hurry. The Agency began responding in late March to mounting public impatience by creating fast-track procedures for badly needed supplies.
FDA 510k Consultants, LLC, specializes in but one thing—steering its clients’ medical devices through FDA’s regulatory maze, so they are available to consumers and health care professionals nationwide. A daunting task at any time, this process requires special attention in the present changing environment.
We’re up to that difficult challenge. We’re here to help you navigate FDA’s new rules. America needs help and needs it fast—both yours and ours.
Callers like you have flooded our company with requests since late February. For the following device categories, here’s the latest that we’re telling them:
- Face Masks Not Intended To Provide Liquid Barrier Protection: Labeling must describe product as “face mask” and list body-contacting materials. Labeling also must recommend against use in surgical setting, around hazardous fluids, or near high intensity heat source or flammable gas. And labeling cannot include uses for anti-pathogenic protection or infection prevention, nor make particulate filtration claims.
- Face Masks Intended To Provide Liquid Barrier Protection: Must meet fluid resistance testing (ASTM F1862). Must meet flammability requirement (16 CFR 1610) or labeling must recommend against use near high intensity heat source or flammable gas. Labeling must describe product as “surgical mask” and list body-contacting materials. And labeling cannot include uses for anti-pathogenic protection or infection prevention, nor make particulate filtration claims.
- Respirators Approved By Europe (EN 149), China (GB 2626), Japan, Korea, or Mexico: Importers should verify authenticity of products.
- Infrared Thermometers: Device must have marketing authorization for Europe (CE Mark), Australia, Canada, or Japan; otherwise, it must comply with certain standards listed in EUA. Labeling must describe device performance, method of determining temperature, potential risks, and cleaning/reprocessing instructions. It must also describe device as not cleared by FDA.
- Patient Examination and Surgical Gloves: Labeling must accurately describe as sterilized or non-sterile, not claim latex-free, and list body-contacting materials. Labeling must describe patient examination gloves as “unpowdered glove,” while surgical gloves must meet testing for Rubber Surgical Gloves (ASTM D3577). Labeling cannot include uses for anti-pathogenic protection or infection prevention. And labeling must describe device as not cleared by FDA.
During the public emergency, the above PPE products no longer require registration and listing (though doing so will likely help get products through U.S. Customs). Nor do face masks require 510(k) Premarket Notification or respirators require NIOSH approval. Nor are any of these PPEs required to comply with quality system regulation (except for thermometers), reports or corrections and removals, and UDI marking.
If the manufacturer of your device is registered with FDA, have them list the following products with special codes created for public emergencies: Face Masks (QKR) and Respirators (QKU). The Agency has yet to publish special codes for thermometers or gloves, so use the regular ones: Clinical Electronic Thermometers (FLL), Patient Examination Gloves (FMC), and Surgeon’s Gloves (KGO).
For import information on Custom & Border Patrol website, see CSMS #42124872 -Information for Filing Personal Protective Equipment and Medical Devices During COVID-19.
Before Calling Us
Callers generally fall into one of the following four groups:
- Want to start domestic manufacturing of face masks or respirators.
- Want to import PPEs and are willing to sign a contract and pay a $5,000 retainer for our services.
- Want to import PPEs, but not pay for our services until after product has arrived from China and been delivered to a U.S. customer.
- Want to import PPEs, but have source in China pay for our services.
Please DO contact us if you fall into the first or second category.
If you fall into the third or fourth category, please do not contact us. Most of those inquiries lead nowhere; worse, they consume valuable time we could devote to helping clients in the two groups.