Sorry, we were unable to verify the authenticity of this link. If you would like to proceed anyway, click the link below.

https://www.federalregister.gov/articles/2016/08/08/2016-18714/guidance-for-industry-and-staff-deciding-when-to-submit-a-510k-for-a-software-change-to-an-existing?source=govdelivery&utm_medium=email&utm_source=govdelivery