Posted by Michael Wonder on 05 Sep 2018
New program with payers aims to accelerate patient access to medical devices
5 September 2018 - Advancing the public health means helping to make sure patients have access to safe, effective medical products.
Access is a matter of public health. And our commitments to patients don’t stop at the time of a product’s approval. We take many steps to make sure products can be safely accessed in the post-market setting, and that new innovations continue to deliver their anticipated benefits. We actively monitor for safety findings in the post-approval period. We have updated labeling to provide modern guidance to providers and patients. And as part of our dedication to the promotion of public health, we also look for opportunities to help advance wider access to safe and effective innovations.
Patients may not have access to an FDA approved or cleared device in the absence of adequate coverage. So, the FDA recognizes the importance of working collaboratively with the payor community to streamline the path from FDA market authorization to payor coverage and reimbursement.
