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The FDA’s Principal Investigator for 3D Printed Medical Devices is Looking for Industry Feedback and No One is Giving It to Him

by • July 16, 2016 • No Comments

3dp_fdaguidlines_approved_logoMedical applications for 3D printing are a quickly expanding segment of the 3D printing industry, and the innovation may radically alter the way that many medical issues are evaluated and treated. Applications as diverse as inexpensive, customized 3D printed prosthetic devices, patient-specific surgical implants, surgical pre-planning and actually personalized medications all have the medical community changing the way that it thinks of healthcare. 3D printing innovation may futurely lead us into an age of personalized medicine by enabling doctors, surgeons and pharmacists to tailor and fabricate medical devices and drugs for specific individuals, not turn it into weight generated products for the average patient as they are now.

The 3D printed dissolvable adaptation of levetiracetam called Spritam.

The 3D printed dissolvable adaptation of levetiracetam called Spritam.

In the United States, preceding any 3D printed medical device can be marketed and sold it must acquire approval of the Food and Drug Administration (FDA) where it requires to be evaluated for safety. Today the system of evaluation for new 3D printed devices can be tricky and incredibly time consuming for makers. The significant reason is for the reason the innovation is so new that there are no specific standards in place that companies are expected to adhere to preceding submitting products for review. Traditionally maked medical devices may already have these standards in place so companies have a quite clear thought of how they require to be created, what tests they must pass and what materials can and cannot be utilized. Today the FDA is in the system of writing these regulations for 3D printed devices, and in May they released a draft of their Technical Considerations for Additive Manufactured Devices to the public for review.

“Most of the specifications right now are on the basic materials, bio formats, descriptive terms. We’re attempting to bring understandledge of FDA many practices, understandledge of our regulatory requirements to the additive manufacturing standard so we can assist foster industry growth, by letting them understand what they require to do, letting them have clarity in things like testing methods,” explained James Coburn, the principal investigator for the FDA’s Center for Devices and Radiological Health.

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Having these guidelines in place can be a massive development for 3D printed medical devices, and can contribute worthwhile guidance to the developers and makers of these products. When the draft is finalized, it can lay out a clear roadmap for companies submitting products for review and to donate them the many accident possible of it being approved. It can in addition be a significant validation for the viability of 3D printing innovation in general, and can many most likely lead to an uptick in the development of additively maked medical products and services. The FDA has may already evaluated and cleared 85 3D printed medical devices and 1 3D printed prescription drug, and they are unquestionably motivated to clear additional. In addition to the released draft laying out the future guidelines that the FDA is considering putting in place, it in addition focuses on specific areas where they believe the innovation can make the many impact.

James Coburn, the principal investigator for the FDA’s Center for Devices and Radiological Health.

James Coburn, the principal investigator for the FDA’s Center for Devices and Radiological Health.

“With patient-specific devices, there are a lot of areas where individuals have been considering of doing this, but it’s been cost prohibitive or technologically prohibitive, and 3D printing has opened up a lot of those doors,” continued Coburn.

Among the devices that have may already been cleared by the FDA are orthopedic implants that can be 3D printed to fit the patient’s body precisely and patient-specific surgical instruments that can be 3D printed to assist doctors speed up the surgical system. These types of products were cleared via the federal agency’s current regulatory oversight over medical devices and drugs, that is not always the thoughtl method of evaluation. It is in both the medical community’s and the makers’ many interest to have accurate and specific regulations in place both to encertain the products’ safety and to speed up the review system.

The EndoLIF On-Cage 3D printed titanium spinal implant.

The EndoLIF On-Cage 3D printed titanium spinal implant.

Whilst all federal agency guidelines usually are released in draft form to the public just for transparency’s sake, when it comes to 3D printed medical devices the require for specificity is vitally significant. Because the innovation is yet considered emergent and evolving, the feedback and input of the industry that the FDA can be regulating is going to be invaluable to the final technical considerations. The FDA considered the draft their “initial thoughts” on the subject and have opened the document up for comment through August 8th, 2016. But according to The Hill so far they have just got 3 public comments since the draft was released in May.

I quite can’t stress how significant feedback of the 3D printing industry is to manufacturing certain that the FDA gets this right. Frankly, it is much simpler to effects the rules preceding they are written than it is to alter them after they have been written. The companies that make 3D printed medical devices, implants and surgical tooling should be manufacturing the review of the draft a priority. After all, as Coburn notes “This just gets advantageous with outside expertise”. You can learn additional of how the FDA reviews 3D printed medical devices and follow the system of finalizing the draft of the actuallytual guidelines here. Discuss additional in the FDA 3D Printing Regulations forum over at 3DPB.com.