US FDA Custom device

 Regulatory Authority: Section 520(b) of the Food, Drug, and Cosmetic Act (FD&C Act) provides the basis for the Custom Device Exemption Program.

Types of Custom devices,

Patient-centric: Device is made to treat a patient’s sufficiently rare condition

Physician-centric: Device is made to satisfy a physician’s unique special need remains with that physician for use in his/her practice

Also note that a single device cannot be patient- and physician-centric.

To qualify as a custom device. The following requirements needs to be followed. The following figure shows the FDA requirements.

Custom devices are exempt from 510(k) and Premarket Approval (PMA) submissions.

Custom Devices are not exempt from any other requirements, including, but not limited to,

• Quality System Regulation, including Design Controls (21 CFR Part 820)
• Medical Device Reporting (21 CFR Part 803)
• Labeling (21 CFR Part 801)
• Corrections and Removals (21 CFR Part 806)
• Registration and Listing (21 CFR Part 807)

Clinical investigations of custom  devices cannot be practically conducted because they are used to treat sufficiently rare conditions or rare physician needs.

In addition to 21 CFR 801 labeling requirements, Custom device shall have below information,

• a statement that the device is a custom device
• the name of the ordering physician
• identifying information for the patient (if applicable) whom the device is intended to treat
• indications for use
• sterilization status
• relevant composition information (materials, components, etc.)
• storage conditions.

Click here to know European MDR Custom made device.

 References:

CDRH Learn Custom device

CustomDevice Exemption-Guidance