To legally market a medical device or IVD for human use in the US market, appropriate documentation must be submitted to the US regulatory authority, the FDA (Food and Drug Administration)
Depending on the device risk class, the US regulatory submission can either be a 510(k), Premarket Approval (PMA), or a De Novo request.
The type of regulatory submission you need is tied to the risk classification of your medical device:
The 510(k) is a premarket notification required for medical devices and IVDs to be placed on the US market. It is called a 510(k) because it references section 510(k) of the Food, Drug, and Cosmetic Act, which requires medical device manufacturers to notify the FDA of their intent to market a medical device.
Contrary to popular belief, the 510(k) is not a market authorization for medical device sales. Instead, it is a collection of documents demonstrating that the medical device in question is substantially equivalent to a device already marketed in the US market in one of the three classification categories (Class I, Class II, Class III).
According to Section 510(k), medical device manufacturers are required to submit a 510(k) submission when:
510(k) submission is required for the following medical device manufacturers introducing a medical device to the US market:
Manufacturers who produce finished devices sold according to their specifications or accessories sold to the end user.
Specification developers: When a developer produces the specifications for a finished device, but the device is manufactured by a contract manufacturer or other firm or entity, the specification developer must submit the 510(k) application
Repackagers or relabelers that significantly affect the device, operations, or labeling must submit a 510(k).
Any foreign manufacturer who produces finished devices and wants to introduce them to the US market.
As mentioned previously, the 510(k) clearance depends on demonstrating that your medical device is substantially equivalent to a predicate device, i.e., a device already on the market.
A device legally marketed in the US that is used as a comparative device for medical device manufacturers wishing to place their product on the US market.
A device substantially equivalent to a predicate device.
Substantially equivalent devices do not need to be identical to the predicate but must share critical features with the predicate device. They should either have:
Suppose the 510(k) submission is cleared. In that case, the applicant receives a letter confirming that the device is substantially equivalent to a predicate device in the eyes of the FDA and can be legally placed on the market.
The following devices and manufacturers are exempt from the 510(k) requirement:
Unlike the 510(k), premarket approval (PMA) is a market authorization to legally market a medical device. The PMA is the strictest regulatory submission in the FDA and is required for Class III medical devices. Class III devices are the highest risk classification in the FDA and include devices with the highest impact on the patient in case of malfunction.
Medical devices requiring a PMA often include new concepts or technologies unlike those already marketed in the US.
De Novo devices are Class I or II medical devices that are unlike anything already in the market (no predicate device exists), thus denying them the option of substantial equivalence and the 510(k). The De Novo request classifies the novel medical device so the device can be legally marketed in the US.
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