Zdrowie i gospodarka · 3/8/2011
Medical Device Reporting; Malfunction Reporting Frequency
The Food and Drug Administration (FDA) is clarifying that device manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation, pending future FDA notice under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).