Pre-Sub

US FDA Maps Out Pre-Submission Meeting Options for Medical Device Applicants

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidance on how to utilize its Q-Submission Program for medical device manufacturers before they submit premarket applications.
  • Following MDUFA IV, FDA has revised scheduling and timeframe processes for the Q-Sub program.

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.

US FDA Explains its Approach to “Real-World” Evidence and Data for Medical Devices

Recent guidance from US medical device market regulators explains when and how real-world data and evidence obtained via methods other than clinical trials are used to make market authorization and related decisions pertaining to the products they oversee.

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.

US FDA Explains Criteria for Accepting Medical Device Clinical Data from Foreign Studies

New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in foreign countries, and also outlines criteria the agency uses for accepting such data as part of medical device premarket registration submissions.

US FDA Rolls Out Expedited Access Program for Medical Devices

US medical device market regulators are launching a new expedited market access program for select high-risk devices targeting life-threatening diseases or ailments.

US FDA Updates Guidance on Feedback Mechanisms for Medical Device Registrants

US medical device market regulators have updated guidance first issued in 2012 on the FDA’s Pre-Submission feedback program for medical device manufacturers undergoing Investigational Device Exemptions (IDE), Premarket Approval (PMA), 510(k) premarket notification or other premarket reviews.

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