[Anonymous]

Reply To: Medical Device Labels When Manufacturer Does Not Use Expiry

You can use a legally marketed commercial medical device as an investigational device, even one without a labeled expiration date, provided that its use is within the scope of a clinical investigation plan approved by regulatory authorities. The key factor is not the device’s commercial availability or its expiration date, but rather the intended use within the study. The investigational device exemption (IDE) regulatory pathway is triggered when a legally marketed device is being used for a different purpose than its cleared indication. If you plan to use an already marketed device for an “off-label” or new investigational purpose, it is subject to the same regulatory requirements as a completely new device.

Investigational Device Exemption (IDE): You must apply for an IDE or similar depending of the country of use for a new or significantly modified use of a legally marketed device. This is required to collect the safety and effectiveness data needed for a new marketing application

Significant risk vs. non-significant risk: The level of regulatory oversight and the specific requirements for the IDE depend on whether the study involves a “significant risk” or “non-significant risk” to patients.

Informed consent: You must still obtain informed consent from all participating patients, which includes explaining that the device is being used for an investigational purpose.

Labeling: The device must be labeled with the following statement: “CAUTION—Investigational device, for investigational use only”.

When using a marketed device with no expiration date for an investigation, the key considerations are:
-Document the device: The IDE application must reference the FDA-approved label for the commercially available device.
-Justify the shelf-life: While you can be exempt from submitting new manufacturing data, you must provide information that supports the safety of the device’s use in the study. Your application should confirm that the device is fit for its investigational purpose.
-Accountability: Investigators must maintain detailed records of the receipt, use, and disposition of the device. This is a standard requirement for all investigational devices, regardless of their commercial status.