EMERGO SUMMARY OF KEY POINTS:

• US FDA final guidance issued for additive manufacturing and 3D printed medical devices
• Final guidance hews closely to draft version
• US regulators planning larger effort to develop regulatory framework for 3D printed devices

US medical device market regulators at the Food and Drug Administration have issued final guidance on design, testing and related issues pertaining to additive manufacturing and 3D printed devices.

FDA characterizes the final guidance as both a “comprehensive technical framework” for 3D printed devices and a “leapfrog guidance,” serving as a platform for the agency to air initial thoughts and approaches regarding new and burgeoning medical device technologies and subject to change according to new developments in the additive manufacturing arena. Draft FDA guidance on additive manufacturing, covered by Emergo, was issued in May 2016.

As in its draft form, the final guidance covers general and patient-matched device design, software workflow considerations, material controls and process validation, quality data and testing issues.

Toward a more comprehensive regulatory pathway

In a statement announcing the final guidance, FDA Commissioner Scott Gottlieb noted that the agency is anticipating larger numbers of 3D printed medical devices submitted for US market registration in the future; FDA in turn has begun developing a “more comprehensive regulatory pathway” for timely and effective premarket review of these products.

Next steps Gottlieb identified for furthering a clearer registration pathway for 3D printed devices include:

• Determining which existing US laws and regulations apply to additive manufacturing
• Developing a transparent policy to oversee 3D printing processes
• Reviewing regulatory issues pertaining to bioprinting of biological and tissue-based products

So far, according to Gottlieb, more than 100 3D printed medical devices have undergone FDA premarket review.

Additional FDA regulatory resources from Emergo:

• US FDA registration consulting for medical device and IVD companies
• Medical device material and chemical characterization testing support
• Cybersecurity support for network-connected medical devices and software
• Medical device design, process and software validation consulting
• Whitepaper: Overview of regulations for 3D printed medical devices