AdvaMed, J&J Call On FDA To Better Articulate 3D Printing Regulation

By Jof Enriquez,
Follow me on Twitter @jofenriq

The Advanced Medical Technology Association (AdvaMed) and several medical device companies are encouraging the U.S. Food and Drug Administration (FDA) to state in more precise terms its regulatory approach to 3D printing, otherwise known as additive manufacturing (AM).

FDA had approved 85 3D-printed devices as of December 2015, according to RAPS. That number is likely to rise as 3D printing technology continues to advance. Research firm Gartner predicts that, within the next two to five years, 3D-printed internal and external medical devices will be in mainstream use, writes Myles Whiting of Owen Mumford Ltd.

Industry, however, feels like FDA regulation barely keeps pace with the fast innovation in 3D printing, and has urged the agency to elucidate its approach.

FDA responded with a "leap-frog" draft guidance in May, which the agency stated was not meant to be a comprehensive document tackling all facets of still-evolving 3D printing technology as used in medical devices. The document, however, did address two areas of medical device development: Design and Manufacturing Considerations (including Quality System (QS) requirements), and Device Testing Considerations.

In comments to the draft guidance — accepted through Aug. 8, 2016 — industry stakeholders raised separate issues for the FDA to consider.

AdvaMed commented that FDA should provide a separate, stand-alone companion guidance for patient-matched devices that addresses not only AM, but also other manufacturing technologies, such as computer-controlled milling machines. FDA should also make known its current thinking on issues such as data-handling aspects of patient-specific information, privacy, use of patient data for optimization purposes, and informed consent that are not unique to additive manufacturing alone.

Johnson & Johnson (J&J) stated that there indeed is a "significant benefit to separating patient-matched device considerations into a separate companion guidance document," and pointed out that these considerations are "distributed throughout the current draft and in places it is unclear whether the considerations being addressed are specific to patient-matched devices or AM in general."

AdvaMed also urged FDA – in the interest of patient safety, but subject to enforcement discretion – to add "a statement to this Draft Guidance that a point-of-care establishment that installs 3D printers and uses those 3D printers to routinely manufacture devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA), are subject to relevant FDA requirements, including premarket review if applicable, and post-market controls such as establishing and maintaining quality systems, and adverse event reporting."

J&J stated that addressing point-of-care manufacturing and regulatory expectations in final guidance is of "paramount importance."

Some 3D printing technology soon "may cause a surge of point-of-care manufacturing at healthcare facilities and practitioner offices," and FDA needs to establish guidance and framework for regulating 3D printing by these non-traditional entities, according to Matt Jacobson and Kevin Madagan of Reed Smith LLP’s Life Sciences Health Industry Group.

3D printing company Materialise encouraged FDA to "explicitly recognize the role of Quality Management System" and recommends "a risk based approach that is appropriate to the specific device, rather than a one-size-fits-all approach in which all considerations for additive manufacturing are universally applicable to all types of additively manufactured medical devices." 

AdvaMed urges the Center for Devices and Radiological Health (CDRH) to continue to take the lead in working with “its counterparts within the Agency to facilitate discussions on best practices throughout the Agency. For instance, this issue may be appropriate to present to the Combination Products Policy Council. This discussion and leadership by CDRH will be especially helpful, not only to manufacturers, but FDA field compliance officers as the move to a product-type inspection program moves forward."

In separate comments, companies Zimmer Biomet, Stryker, Smith & Nephew, and Materialise expressed their support for AdvaMed's comments and suggestions.