Sep 29, 2016


  • The FDA has signed up seven insurers and health technology assessment (HTA) organizations to participate in pre-submission meetings with medicla device clinical trial sponsors upon request.
  • US regulators believe that involving reimbursement providers earlier in premarket authorization will give device companies a clearer idea of how their products will be covered after commercialization.
  • The FDA states that although reimbursers may participate in pre-sub meetings, device safety and effectiveness issues will remain paramount in determining whether and how clinical trials occur.

The US Food and Drug Administration has identified reimbursement providers willing to participate in pre-submission meetings with medical device manufacturers to reduce reimbursement obstacles and improve patient access to new devices.

The Payer Communication Task Force, part of the agency’s Center for Devices and Radiological Health (CDRH), called in early 2016 for private payer and health technology assessment organizations to voluntarily attend pre-sub meetings alongside regulators and medical device clinical trial sponsors in order to help identify clinical evidence that would help coverage providers make faster reimbursement decisions. Now, CDRH has identified seven reimbursement providers willing to take part in pre-sub meetings:

  • BlueCross BlueShield Association
  • Duke Evidence Synthesis Group (Duke Clinical Research Institute, Duke University)
  • ECRI Institute Headquarters
  • Humana
  • Kaiser Permanente
  • National Institute for Health and Care Excellence (NICE)
  • SelectHealth/Intermountain Health

Going forward, medical device clinical trial sponsors have the option of contacting CDRH to request that an organization from the list above participate in a pre-sub meeting. (Sponsors must submit such requests before submitting pre-sub materials for CDRH reviewers.)

Involving reimbursement providers earlier in the medical device market authorization process—at least for those requiring clinical trials before commercialization—may allow manufacturers more predictability once they obtain FDA clearance or approval, so long as US regulators ensure that clinical evidence for these devices focuses on safety and effectiveness.  


  • Stewart Eisenhart