Feb 29, 2016

The US Food and Drug Administration is gauging interest from insurers and health technology assessment groups for greater participation in pre-submission meetings for medical device clinical trials.

In a recent notice, the agency has requested “expressions of interest” from coverage organizations—insurance providers, health technology assessors and related entities—as to whether these organizations would be willing to provide more input into medical device clinical trial sponsors’ study designs and related issues.

By involving coverage organizations during the pre-sub process before clinical trials are finalized and conducted, medical device registrants may be able to better address questions and concerns from providers and positively impact coverage and reimbursement recommendations based on clinical evidence, according to the FDA.

In cases where a coverage organization does agree to provide such input, FDA personnel will provide a clinical study sponsor the option of requesting that the coverage organization participate in a pre-sub meeting.

If coverage organizations agree to participate, their input could result in clinical trial designs able to address both FDA clearance or approval requirements and providers’ requirements for positive coverage decisions pertaining to devices.


  • Stewart Eisenhart