- See the FDA Payor Communications Page here.
- See the FDA Drug & Device Payor Communications Guidance, here.
- 26 pages, PDF, June 2018.
- See Gottlieb statement about the value of FDA-Payor interactions, here.
- See an archived commercial webinar on FDA's package of payor communications at Icon, here.
Sections on the FDA Payor Communications Page include:
At the bottom of the webpage are a number of links to various Commissioner statements, Federal Register publications, etc. For example, FDA last held a "Payor Summit for Medical Devices" three years ago, in 2016.
You can also request an FDA speaker to come talk about these policies at an event or conference (instructions on the webpage).
- An overview and background section;
- A voluntary Commercial Payor section
- Includes Aetna, Kaiser, Cigna, Humana, etc., and evidence groups like ECRI;
- Instructions and contact information for the "CMS-FDA Parallel Review" process.
At the bottom of the webpage are a number of links to various Commissioner statements, Federal Register publications, etc. For example, FDA last held a "Payor Summit for Medical Devices" three years ago, in 2016.
You can also request an FDA speaker to come talk about these policies at an event or conference (instructions on the webpage).