pre-submission

FDA Clarifies Early Feasibility Study (EFS) Program for Early-stage Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has provided qualification and submission details for its Early Feasibility Study (EFS) program.
  • The EFS program targets novel and innovative devices for which little or no prior clinical and non-clinical data exist.

FDA Final Guidance Issued on Key Factors for IDE Benefits, Risks

EMERGO SUMMARY OF KEY POINTS:

  • Final FDA guidance explains how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered.
  • The guidance finalizes draft recommendations issued by the FDA in 2015.
  • The guidance includes recommendations for benefit and risk information IDE applicants should submit to the FDA for review and approval.

US FDA Lists Reimbursers Interested in Attending Pre-Sub Meetings for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • 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.

FDA, NIH Propose New Clinical Trial Protocol Template for Investigational Device Exemptions (IDE)

The US Food and Drug Administration and the National Institutes of Health (NIH) have jointly proposed a new template for clinical trial sponsors to use for submitting Investigational Device Exemption (IDE) applications.

US FDA Seeks Reimbursers' Input for Medical Device Clinical Trials

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.