FDA Takes on 3D Printing in New Draft Guidance

With 3D printing — also known as additive manufacturing — taking off, the FDA is playing catch up to provide needed industry guidance.

To that end, the FDA has offered its preliminary thinking on technical considerations specific to 3D-printed devices.

In draft guidance released May 10, the FDA concentrates on two topic areas: design and manufacturing considerations and device testing issues.

The first section addresses what sponsors should keep in mind to meet quality system requirements, while the latter delves into what information should be provided in 510(k)s, PMAs, HDEs, IDE applications and de novo requests for 3D-printed devices.

As the document notes, there are a number of technologies and processing steps that can be used in creating a 3D-printed medical device; therefore, it’s essential to identify each throughout in the design and manufacturing phases. The agency recommends creating a production flow diagram to document the steps from the initial design phase to post-processing.

Further, the cumulative effects of previous processes on the final device or component should be outlined to help determine the root cause of any potential failure.

The document also notes that manufacturers should consider whether the device will be of a predetermined size, as well as how the product can be tailored to a patient’s unique anatomy.

Software

How software from different manufacturers will interact also should be addressed to avoid errors during file conversion. For example, images from MRIs or CT scans, design manipulation software for patient-matching and machine-readable files all have unique standards, coordinate systems and default parameters.

“Errors in file conversion can negatively impact final finished device and component properties, such as dimensions and geometry,” the document notes.

Stakeholders are advised to test all file conversion steps using worst-case scenarios. “Factors that may cause unexpected conversion failures, such as changes to the software used, may trigger the need for revalidation,” according to the FDA.

The FDA recommends that final device files “should be maintained and archived in robust, standardized formats that are able to store AM-specific information.”

In addition, the document includes information on the type of information for testing, addressing biocompatability and labeling considerations. For the latter, the document says each patient-matched device should include a patient identifier; details identifying use, such as anatomical location; and the final design iteration or version used to produce the device.

While providing a broad overview of manufacturing and testing, the document doesn’t cover the use of biological, cellular or tissue-based products in AM. “Biological, cellular or tissue-based products manufactured using AM technology may necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways,” according to the document, which says that any questions about products containing these materials should be directed to representatives from CBER.

The document — which builds on discussions from an October 2014 workshop on AM —is what the agency calls a “leap-frog guidance,” which aims to provide the agency’s initial perspective on emerging technologies.

The FDA isn’t the only entity touting 3D printing for devices recently. UPS and the Consumer Technology Association released a study on the rise of 3D printing that highlighted the processes’ success in the medical device industry. According to the paper, the medical device arena is the third largest 3D printing market, and 98 percent of hearing aids worldwide are manufactured using the process.

Read the draft guidance here: www.fdanews.com/05-16-16-FDAAdditive.pdf. Check out the study here: www.fdanews.com/05-16-16-ups-CTA.pdf.