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.

Medical device companies conducting certain types of clinical trials may now rely on central rather than local Institutional Review Boards (IRB) for reviews required by the US Food and Drug Administration.

In accordance with the 21^st Century Cures Act of 2016, the FDA’s Center for Devices and Radiological Health (CDRH) has issued a technical amendment allowing sponsors conducting clinical studies for Humanitarian Device Exemption (HDE) devices to utilize central IRBs to review their activities; previously, clinical trial sponsors and sites were required to undergo such reviews by local IRBs. The allowance for central IRB review applies to Investigational Device Exemption (IDE) studies, and for multi-site clinical studies, as well.

This IRB oversight change is intended bring drug and device regulations more closely in line with one another, according to the FDA.

Additional FDA and clinical resources from Emergo:

• US FDA consulting services for medical devices and IVDs
• FDA Pre-Sub consulting support for medical device companies
• Medical device clinical research study auditing
• US FDA regulatory process chart
• Whitepaper: Clinical data to support 510(k) applications