The U.S. Food and Drug Administration (FDA) is soliciting public comment on the discussion paper — — released Dec. 10. The paper describes early, nonbinding agency perspectives about 3D printing of medical devices within healthcare facilities. The deadline to is Feb. 8.
The paper defines three types of scenarios in which medical devices are printed within healthcare facilities and solicits feedback on the identifying characteristics of “very low risk” devices in need of regulatory flexibility. Feedback provided to FDA on these concepts will likely inform the agency’s future development of draft guidance.
For more information or to provide feedback for potential inclusion in the 黑料网® (黑料网®) comment letter, please contact Michael Peters, 黑料网 Government Affairs Director.