The FDA 510(k) or Premarket Notification is applicable mainly to Class II devices as per FDA Classification intended for use on humans, with mild to moderate risks, before it can be marketed in the US. Some Class I and III medical devices also come under the scope of 510(k). This technical dossier is used to prove that the device is safe and effective. The request 513(g) is submitted to FDA for confirmation of classification, if the classification of the device cannot be determined. Pre-submission process is used by applicant to obtain feedback from FDA before actual submission for the 510(k) clearance.
The process for getting 510(k) clearance involves comparison of the device with one or more devices that are already marketed in the US legally. The applicants should claim and prove the substantial equivalence to the predicate device. To prove substantial equivalency, both devices should have the same intended use but any difference in the technological characteristics are overlooked as long as the safety and effectiveness are not compromised.
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Is there any class II devices exempted from 510k? Can you mention any of them? Is there any reason for this exemption?
Not only class II devices, most of class I and some Class II devices are exempted from 510k requirements. A device may be exempt from 510(k) requirements if it is not required to provide reasonable assurance of safety and effectiveness for the device.
Medical Device Exemptions 510(k) and GMP Requirements are listed in the below link and can found in Medical Device Exemptions 510(k) and GMP Requirements website.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
Most Class I devices and some Class II devices are exempt from 510(k) requirements, but they must still comply with other regulatory controls unless the device is explicitly exempt from those requirements in the regulation for that device type.
For example, air-handling apparatus for a surgical operating room and uncoated steel monofilament sutures without barbs are Class II devices, which are exempt from 510(k), but are still subject to Good Manufacturing Practice.
The exemption of these devices are subject to certain limitations.
1. The exemption is extended only to generic devices that have existing or reasonably foreseeable characteristics of devices that are commercially distributed in the market. In vitro diagnostic devices that are not associated with high morbidity or mortality due to misdiagnosis resulting from the use of the device are only exempt from 510(k) requirements.
2. Preamendment devices which have been legally marketed in the U.S. before the enactment of the Medical Device Amendments on May 28, 1976 are also exempt from 510(k) requirements if they have not been significantly changed or modified since then and if the Premarket Approval has not been deemed necessary to provide reasonable assurance of the device’s safety and effectiveness by the FDA.
Stainless steel suture is an example of the class II 510(k) exempt with the equal of product code GAQ, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act.
For the above device type premarket notification (510(k)) is not required if it does not exceed the general limitations of exemption which is there in 21 CFR 878.9 and the specific limitations of exemption as defined in the “Physical State” field of this product code description. This exemption is limited to steel monofilament sutures which are uncoated and do not incorporate barbs.
Food and Drug Administration (FDA) for class II devices has also circulated a list of class II (special controls) devices with some limitations, that are exempt from premarket notification which required under the 21st Century Cures Act of 2016 (Cures Act) and Food and Drug Administration Modernization Act of 1997 (FDAMA).
As per FDA’s consideration these exemptions will relieve the submitters from the need to submit premarket notification submissions for these devices and also enables FDA to redirect the funds to more significant public health issues instead on reviewing such submissions. Hence, FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.