investigational device exemption

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.

US FDA Rolls out New Market Pathway for Breakthrough Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA is launching a new expedited registration route for breakthrough and innovative medical devices.
  • The Breakthrough Devices Program covers qualifying 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and de novo applications.
  • The program entails earlier interactions between regulators and manufacturers during product development.

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.

US Regulators Change IRB Requirements for Some Medical Device Clinical Trials

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA no longer requires local Institutional Review Board (IRB) review of medical device clinical studies for Investigational Device Exemptions (IDE) and Humanitarian Device Exemption (HDE) devices.
  • Instead, qualifying clinical trial sponsors may utilize central IRB reviews as part of their US market authorization processes.

In Brief: Clinical Trial Protocol Writing Tool from US FDA, NIH Now Available

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA and National Institutes of Health have launched a new writing tool for medical device companies seeking approval to conduct clinical trials.
  • The new clinical trial protocol template was first proposed in early 2016.
  • The template is intended to help applicants seeking Investigational Device Exemption (IDE) approvals.

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.

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 Report Claims Improving RTA Rates, Reduced Medical Device Review Timeframes

A new report released by the US Food and Drug Administration shows a substantial reduction in instances where incomplete premarket applications are refused under the agency’s Refuse to Accept (RTA) policy, as well as decreases in overall review timeframes for medical device clearances and approvals between 2010 and 2014 fiscal years.

New US FDA Guidance: Six Benefit-Risk Factors to Include in Medical Device IDE Applications

In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the US Food and Drug Administration has published new guidance explaining key issues the agency uses to assess benefits and risks of IDE submissions for clinical investigations of Class III and some Class II medical devices.

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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