|All medical products (USD million)||$1,159,674 (+16.1%)|
|Medical equipment||$150,985 (+7.2%)|
|Medical supplies||$204,391 (+18.5%)|
|Test kits & diagnostic reagents||$39,249 (+39.4%)|
|Personal protective products||$201,071 (+44.2%)|
|Face masks||$136,257 (+76.6%)|
Before you export your medical device to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.
Diagnostic tests, ventilators, and personal protective equipment (PPE), including surgical masks, face shields, respirators, gowns, and gloves, are regulated as medical devices.
Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the FDA. However, additional requirements apply.
FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threat agents, when certain criteria are met, including there are no adequate, approved, and available alternatives.
The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.
Which N95 respirators are not exempt from Premarket Notification 510(k)?
- intended to prevent specific diseases or infections
- labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity
- contains coating technologies unrelated to filtration (reduce and or kill microorganisms).