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:
- Alternative production method for conventionally manufactured device components
- Primary production method for developing customized, “patient-matched” devices
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.
REFERENCE: Emergo Group; Stewart Eisenhart; 23 MAY 2014