May 23, 2014
US medical device market regulators are putting the burgeoning practice of 3-D printing for medical devices under the microscope, having announced a public workshop on the issue in October 2014 at the Food and Drug Administration’s headquarters.
The use of 3-D printing, also known as additive manufacturing, allows production of medical devices via computerized modeling rather than typical building materials. These techniques have allowed for more efficient production of prototype, small-batch and customized medical devices; although few manufacturers have thus far adopted 3-D printing for device development and production, the FDA anticipates that the practice will gain popularity for both conventional and cutting-edge production methods:
The FDA reports that agency reviewers have already begun receiving 510(k) premarket notification and premarket approval (PMA) submissions that include 3-D printing as primary and alternative device production methods.
The agency intends to discuss technical aspects and best practices related to 3-D printing at the workshop in order to, among other things, “coordinate future collaborations in the development of educational materials, standards and guidance.” The notice makes no explicit mention of regulatory action per se, but clearly that possibility is now on the table.
A new draft report by the US Food and Drug Administration proposes establishing a nationwide framework for regulating health information technology and medical devices. The FDA’s new proposals would involve three federal agencies (The FDA, Federal Communications Commission and the Office of the National Coordinator for Health Information Technology) in oversight of mobile medical apps and related technologies, and are intended to coordinate the roles of those regulators.
Testifying before a US House of Representative hearing on mobile medical technology on March 21st, FDA official Christy Foreman indicated that the agency’s approach to mobile medical app oversight will not include smartphones or tablets used to access such devices.