Certain medical devices must provide an electronic copy (eCopy) of their submission. An eCopy is a duplicate of the paper copy that is submitted to the FDA, and may be submitted on a CD, DVD, or flash drive. The purpose of an eCopy is to improve the review process by making a submission available immediately. The updated guidance document “eCopy Program for Medical Device Submissions” was … Read More
MDDS, Medical Image Storage Devices, & Medical Image Communications Devices Final Guidance
The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance has been released. The FDA posted a regulation down-classifying Medical Device Data Systems (MDDS) from Class III to Class I on February 15, 2011. Class I devices are subject to general controls under the FD&C Act. A draft guidance regarding MDDS was issued on … Read More