But, Section 520(o)(1)(B) of the FD&C Act, states that software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a device under section 201(h) of the FD&C Act.
Before you export your medical device to the United States, register your compan with the U.S. Food and Drug Administration, to avoid the detention of your shipment. Initial Importers are also required to register their establishments.
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.
When an entry is transmitted during customs clearance, the FDA verifies that the declared manufacturer and shipper are registered, by searching the CDRH’s establishment registration and listing database. The agency also uses CDRH’s data system to verify that the declared importer is registered.
Moreover, if the information does not match, the FDA may gather additional information, or may detain the product. In case a firm lacks the required registration and listing, the product will be subject to refusal.