Jul 21, 2016 | By Benedict

The FDA’s draft guidance on 3D printed medical devices, released in May and open for comment until August 8, has received just three public comments. The FDA had sought to receive significant industry feedback on its draft in order to devise a fair and comprehensive set of rules.

When the Food and Drug Administration (FDA) released its long-awaited draft guidance for 3D printed medical devices back in May, it was hailed as an important moment in the history of medical 3D printing. At present, producers of 3D printed medical devices and drugs must deal with long delays as the FDA chooses whether or not to grant approval for a product. This process has been made especially difficult for producers because, until May, there had been no official guidance from the FDA on what it considered safe or unsafe practice in 3D printed device manufacture. With the introduction of the new guidelines, it had been hoped that approval would become a much simpler process, with producers able to identify approval criteria before developing a product.

The draft guidance for 3D printed medical devices, divided into two broad categories of “Design and Manufacturing Considerations” and “Device Testing Considerations,” represent the FDA’s “initial thoughts” on the subject—thoughts which require outside expertise in order to become fully developed. “Most of the specifications right now are on the basic materials, bio formats, descriptive terms,” said James Coburn, a senior research engineer for the FDA’s Center for Devices and Radiological Health. “We’re trying to bring knowledge of FDA best practices, knowledge of our regulatory requirements to the additive manufacturing standard so we can help foster industry growth, by letting them know what they need to do, letting them have clarity in things like testing methods.”

Making the epilepsy medication Spritam, the first FDA-approved 3D printed drug

The FDA has so far cleared 85 3D printed medical devices and a 3D printed epilepsy drug called “Spritam,” but these approvals were each made through FDA oversight of medical devices and drugs, a process slower than that which could be implemented when the 3D printing guidance is finalized. Current 3D printed medical devices include orthopedic instruments and surgical implants which can be made to a patient’s specifications using data from CT scans, MRI scans, and other sources. Despite their advantages, 3D printed medical devices must undergo careful scrutiny before they can be approved for medical use, since their materials and structures remain a relatively unknown quantity to the governing body.

According to the FDA, the Design and Manufacturing Considerations half of the guidance “provides technical considerations that should be addressed as part of fulfilling Quality System (QS) requirements for a device, as determined by its regulatory classification or regulation to which it is subject, if applicable.” The Device Testing Considerations section, on the other hand, “describes the type of information that should be provided in premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications for a 3D printed device.”

3D printed medical devices and medallion

The advantages of the new guidance for 3D printed medical devices are at least twofold: for one, having a clear and precise documentation in place which explains how medical devices should be made will enable errors to be identified by the manufacturers during the design stage, rather than by the FDA—an event which would result in non-clearance after time and resources had been dedicated to the product. A second possible advantage is the prospect of the industry itself growing, since the guidance would give startups and other businesses the confidence to invest in a 3D printed product with less risk of it being rejected by the FDA.

When the guidance was released in draft form, the FDA had hoped for significant industry feedback in order to revise and perfect the regulations. In the absence of such feedback, the FDA could be forced to finalize the guidance as it currently stands, potentially obstructing the development of important and perfectly safe products simply because a manufacturer or research group failed to explain in advance how a certain production method or material formulation can be safely utilized.

Public comments on the draft guidance

With the guidance open for public comment until August 8, it is vitally important that 3D printed medical device manufacturers and other experts have their say on the regulations before they are rubber-stamped.



Posted in 3D Printing Application



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