‘The Sky’s The Limit’ For 3-D Printed Medical Devices, FDA Says
This article was originally published in The Gray Sheet
In an interview with “The Gray Sheet,” staff in CDRH’s Office of Science and Engineering Laboratories discuss the center’s research studies on 3-D printers used to manufacture medical devices and describe the challenges and opportunities that lie ahead.
You may also be interested in...
FDA Tackles 3-D Printing Considerations In Draft Guidance
A draft guidance issued by FDA on additive manufacturing, or 3-D printing, of medical devices is meant to be a starting point for an industry that is growing exponentially. The document outlines recommendations on topics such as device design, software considerations and material testing requirements.
3D Printing: Will Personalized Medical Devices Be The Next Big Thing?
Medical device manufacturers have a growing interest in 3D printing, a technology that could upend the manufacturing and distribution of certain medical devices and expand the scope of personalized medicine – especially in orthopedics, where it's used for some models, implants, and surgical cutting guides. Despite uncertainties related to regulation, reimbursement, and scaling up, global 3D printing revenues for medical and dental applications reached an estimated $537.1 million in 2014.
FDA Will Talk 3-D Printing At October Workshop
The Oct. 8-9 workshop will serve as a forum for FDA to collect public input on technical assessments that should be considered for 3-D printed devices to “provide a transparent evaluation process for future submissions.”