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| Beginning August 14, 2015, device makers must submit all medical device reports electronically. |
by Alex Butler, Product Manager
Life Science Applications (LS APPs), MasterControl
In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format via the Electronic Submissions Gateway (ESG), rather than in paper form through Form FDA 3500A. The compliance deadline of August 14, 2015, is fast approaching! Will you be ready?
Here are some last minute tips for going all electronic.
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