Hi everyone,
My company is developing a medical device and is currently drafting our 510k application. The device incorporates a class 2 therapeutic technology subject to a 510k submission, but also a class 1 camera (not therapeutic) that is 510k exempt. The two technologies have two different indications for use.
As far as I can read on FDA's website, the 510k exemption for a class 1 device means that as long as we adhere to the general controls, GMP, etc. we don’t need to submit a 510k application for such a device. However, since we are required to submit a 510k for our class 2 technology anyways, should we still include and compare the class 1 camera in the 510k application, even though it is exempt for this submission type?
To clarify, the two technologies are part of one complete device. Thank you in advance for your time.
My company is developing a medical device and is currently drafting our 510k application. The device incorporates a class 2 therapeutic technology subject to a 510k submission, but also a class 1 camera (not therapeutic) that is 510k exempt. The two technologies have two different indications for use.
As far as I can read on FDA's website, the 510k exemption for a class 1 device means that as long as we adhere to the general controls, GMP, etc. we don’t need to submit a 510k application for such a device. However, since we are required to submit a 510k for our class 2 technology anyways, should we still include and compare the class 1 camera in the 510k application, even though it is exempt for this submission type?
To clarify, the two technologies are part of one complete device. Thank you in advance for your time.