When looking for a COVID-19 test, it’s best to use one that’s been authorized by Emergency Use Authorization, commonly referred to as “EUA.” Here is an overview of EUA and some of the other common terminology.
FDA Authorized: An Emergency Use Authorization (EUA) is one of several tools the FDA is using to help make certain medical products available quickly during emergencies, such as the COVID-19 pandemic. In certain emergencies and after a review of the safety and efficacy of device, the FDA can issue an EUA to provide access to medical products that may potentially be used when there are no adequate, approved, and available options. Since COVID-19 is a novel virus, no previous tests, treatments or vaccines existed so products are authorized by the EUA process.
FDA Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process to demonstrate the benefits outweigh its risks. Following a successful submission of a premarket approval (PMA) or a Humanitarian Device Exemption (HDE), the device is given Approval by FDA. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.
FDA Cleared: When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. This is one of the more common routes for getting a product to market. Medical device companies can use this pathway if they are able to prove substantial equivalence with an existing product. A device is “cleared” if it’s essentially identical to an already-approved device. This usually applies to Class II devices, which are most medical devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.
FDA Exempt: If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Examples of exempt devices are manual stethoscopes, mercury thermometers and bedpans. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.
FDA Registered: Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent.
FDA Listed: Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers, contract sterilizers, repackagers and relabelers, specification developers, reprocessors single-use devices, remanufacturer, manufacturers of accessories and components sold directly to the end user, U.S. manufacturers of “export only” devices. Just because a product is FDA listed, it does not necessary mean that product is authorized, approved or cleared.
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