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.

The US Food and Drug Administration has published new information online explaining how medical device manufacturers may apply and qualify for limited-scope clinical investigations known as Early Feasibility Studies (EFS).

The new FDA webpage explains that EFS targets manufacturers of novel or innovative devices in the early stages of development; these devices have little to no prior clinical and/or non-clinical data available, so data and experience obtained from an EFS may help sponsors and FDA reviewers assess device design concepts as well as clinical safety and performance issues on such products.

EFS program features

First outlined in 2013 FDA guidance, the EFS program features interactive reviews involving manufacturers, regulatory staff and clinicians, as well as program application and submission assistance from FDA staff. The program requires less non-clinical data from manufacturers than the standard Investigational Device Exemption (IDE) route, and is intended to allow speedier modifications to devices and clinical protocols.

Which devices qualify for EFS?

The FDA’s EFS program is open to medical devices that require 510(k) premarket notification, Premarket Approval (PMA), De Novo classification and Humanitarian Device Exemption (HDE) reviews.

“EDS may be applicable when clinical experience is necessary because non-clinical testing is unavailable or inadequate to provide the information needed to advance device development,” states the FDA’s EFS webpage.

Examples of devices that may qualify for EFS include:

• Devices previously qualifying for Compassionate Use approval
• Devices already marketed outside the US
• Registered devices for which manufacturers are proposing new indications

Applying to the EFS program

The FDA has established a four-step process whereby medical device manufacturers may apply for participation in the EFS program:

• First, the manufacturer should contact an EFS program representative in the appropriate Center for Devices and Radiological Health division to discuss the EFS submission process.
• Second, the manufacturer should prepare and submit a Pre-Submission that includes descriptions of its device concept, clinical context and rationale for EFS program qualification.
• Third, the firm should request feedback from CDRH staff on non-clinical testing protocols and related information via pre-submission supplements as needed.
• Finally, the firm should submit a full IDE request.

Related FDA and medical device clinical information from Emergo:

• US FDA 510(k) application consulting service for medical device companies
• Clinical trial study design and protocol development support
• Whitepaper: FDA regulations for novel and innovative medical devices
• Whitepaper: Clinical data to support FDA 510(k) submissions