FDA rolls out draft guidance for 3-D printed medical devices

The Agency’s “leap-frog” draft guidance will give manufacturers a better idea of how to go about making 3-D printed devices and how regulators will approve the products, the FDA said in its guidance.  The new guidance specifically covers two areas of medical device development: design and manufacturing and device testing.  The regulators’ guidance does not cover 3-D printed products that contain biologics, cells or human tissues. And “point-of-care device manufacturing may raise additional technical considerations” not found in the draft guidance, the FDA said, leaving the door open for more review.

The Agency wants manufacturers making 3-D printed devices to follow quality system requirements. Device makers should “clearly identify each step in the printing process … from the initial device design to the post-processing of the final device,” regulators said.  Device makers should also make sure they understand how different manufacturing processes for 3-D printing could affect devices. The “risks identified for each step of the manufacturing process, as well as mitigations of these risks, should be documented,” the FDA said.

In terms of device testing, the FDA said that data for approval should be based on a product’s “intended use, risk profile and classification.”  Testing will also depend on whether the device is implantable or custom-made. Manufacturers should include a range of all possible sizes for custom-made devices, the agency said.

Overall, though, 3-D printed devices will be tested along similar benchmarks to non-3-D printed devices, the FDA said.  Mechanical testing should look at a device’s build to “ensure that production processes are properly developed, conducted, controlled, and monitored to ensure devices or components are not adversely affected by fabrication orientation,” regulators said.

The FDA is giving the public 90 days to submit comments about the guidance.

The Agency drew up the draft guidance based on feedback it got from a 2014 public meeting on 3-D printing. The technology has been growing by leaps and bounds recently.

Regulators see some unique challenges to regulating the devices. But potential advantages to 3-D printing medical devices abound, regulators said in the guidance.  3-D printing “has the advantage of facilitating the creation of anatomically matched devices and surgical instrumentation by using a patient’s own medical imaging.  Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches,” the FDA said.

The draft guidance “likely will not slow down or halt innovation,” Matthew Jacobson, an attorney for Reed Smith and legal expert on 3-D printing, told FierceMedicalDevices in an e-mail.  The Agency’s proposed guidance is in line with standing regulations and includes items that would be “evident” to device manufactuers, Jacobson said.  “Based on the draft guidance, FDA is aware that 3D printing has numerous advantages, but also poses challenges and unique considerations involved in 3D printing of medical devices,” Jacobson said.  “The draft guidance is a starting point, but as more information and potential issues become more evident, regulations will evolve and become more detailed.”

REFERENCE:  Fierce Medical Devices; 11 MAY 2016; Emily Wasserman

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