Clinical trials
Pre-market approval (PMA), PMA post-approval studies, pre-market notification (PMN) 510(k), and 510(k) post-approval extension studies
Read about pre-market approval (PMA), PMA post-approval studies, pre-market notification (PMN) 510(k), and 510(k) post-approval extension studies guidelines related only to percutaneous transluminal…
Pre-market approval (PMA), PMA post-approval studies, pre-market notification (PMN) 510(k), and 510(k) post-approval extension studies
Read about pre-market approval (PMA), PMA post-approval studies, pre-market notification (PMN) 510(k), and 510(k) post-approval extension studies guidelines related only to percutaneous transluminal…
Understanding clinical trials and device coverage
Clinical trials background
What regulatory guidance addresses devices and clinical trials in the Medicare program?
Understanding clinical trials and device coverage
Clinical trials background
What regulatory guidance addresses devices and clinical trials in the Medicare program?
Humanitarian device exemption
First Coast may consider coverage of a humanitarian use device, intended to benefit a small patient population, when the provider follows the specific guidelines and submits the appropriate…
Humanitarian device exemption
First Coast may consider coverage of a humanitarian use device, intended to benefit a small patient population, when the provider follows the specific guidelines and submits the appropriate…
Billing and coding of routine costs
View these billing and coding instructions of routine costs for qualifying clinical trials.
Transcatheter aortic valve replacement (TAVR)
Important information notifying users of the requirements for approval of transcatheter aortic valve replacement (TAVR) studies.
Billing and coding of routine costs
View these billing and coding instructions of routine costs for qualifying clinical trials.
Transcatheter aortic valve replacement (TAVR)
Important information notifying users of the requirements for approval of transcatheter aortic valve replacement (TAVR) studies.