The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal regulations.

Background

Custom medical devices can be thought of as being similar to products made by pharmaceutical compounders: They are similar to already-approved devices, but are custom-made to the specifications of a single patient based on their prescribed needs as determined by a healthcare professional.

Like compounded products, custom devices are mostly exempt from regulation, and are not required to seek premarket approval or clearance. However, they are required to meet standards for good manufacturing practices (GMPs) under FDA's quality system regulation (QSR, 21 CFR 820).

The devices are defined per 21 CFR 812.3(b) as devices not being generally available, not available in finished form, deviated for the needs of a specific patient, not advertised for commercial distribution and intended for a specific patient.

But as with pharmaceutical compounding, the line between a product that requires approval and one allowed to bypass regulatory approval is not always clear. In April 2009, for example, FDA won a case before the US Court of Appeals for the Eleventh Circuit against manufacturer Endotec, which the court found was manufacturing devices and marketing them as "custom" when they were actually subject to FDA regulation. Though FDA won the case, The Gray Sheet reported that left unanswered by the courts was an important question: What line separates a custom device from a commercial one?

The issue was controversial-and important-enough to warrant inclusion in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, Section 617 of which clarified the definition of "Custom Devices" to provide for more leeway for the devices. FDASIA also called upon FDA to issue final guidance to clarify requirements by August 2014.

Final Guidance out

FDA is now out with its final guidance document, clarifying a few points left ambiguous in its January 2014 draft guidance document.

(For more about the substance of the draft guidance, please see our January 2014 story on the custom medical device guidance.)

While much of the final guidance is the same as the January 2014 draft, there are numerous changes meant to reflect many of the comments received by FDA.

For example, the guidance now contains a new section about what to do if a patient must undergo revision surgery to replace a component that is no longer manufactured. A sponsor asked if that component would be a custom medical device. It would not necessarily be a custom medical device, FDA said.

"The component is only a custom device if it is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat and meets all the other requirements of section 520(b)," FDA explained. "That the component is no longer being manufactured does not make the component a custom device. However, under these circumstances, a compassionate use request to allow the component to be manufactured and implanted could be submitted to FDA."

FDA's final guidance also includes ample mention of the fact that companies should provide it with information about when a device is destroyed by the ordering physician. Under FDA's new "five device" policy, the agency won't count extra devices manufactured for a particular patient (sometimes done to accommodate uncertainty about the exact size of a device needed by a patient) so long as they are either returned to the manufacturer or destroyed.

FDA has also added a new section to the guidance regarding its "five unit" definition. The agency says it will now "take into account multiple considerations such as anatomical location, disease state, material, technology and indications."

FDA Custom Device Guidance (FR)

FDA Docket