by Russ Olson, Regulatory Senior Principal Advisor
CDRH’s guidance document for Early Feasibility Studies (“Investigational Device Exemptions (IDE’s) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies”) was issued October 1, 2013. On August 23rd of this year, CDRH announced changes for how it will handle Early Feasibility Studies (EFS) for medical devices and manufacturers should take note.
These EFS studies are typically small in size (up to 15 patients) and generally short term. They’re conducted to develop data that is used to further develop new medical devices or therapies and are not intended to develop adequate data for device approval by itself. Additional IDE supplements are needed for additional clinical studies with different devices until a pivotal study is conducted that is used for device approval.
The long-term goal of FDA was to allow early feasibility studies for innovation of new medical devices while protecting the safety of the patients enrolled in the study. FDA recognized that often the devices used in early feasibility studies are not fully developed medical devices and may not have all the test data expected for final device designs. So, CDRH sought to work with study sponsors to balance pre-study test data and system design to minimize development costs while still protecting patient safety. Primarily using the pre-submission process accomplished this.
Clarification on the Guidance
The announcement leaves the existing guidance documents in place, but adds a specific contact point for each CDRH review group to assist study sponsors. Now it should be easier for sponsors to reach the right CDRH experts to discuss proposed studies and patient safety. A new web page has links to many IDE resource documents and outlines the process the recommend to study sponsors. It also has links to information on the Expedited Access Pathway, another pathway to help certain medical device development efforts reach the market in as short a time as possible. Access the guidance here: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm572934.htm
RCRI has expert design and clinical teams to navigate guidelines, identify the best regulatory pathway, and negotiate the ideal development and clinical study approach for your medical device. Please contact Samantha Thrun at email@example.com or 952-224-2260 to get the discussion started.