Day: September 13, 2018

In a detailed report of the current practices for application review by FDA, the Office of Inspector General (OIG), Department of Health and Human Services, recommended FDA take additional steps to assure that medical devices are protected from cybersecurity issues. These include having sponsors discuss cybersecurity issues at pre-submission meetings, adding cybersecurity assessment in the … Read more

This week FDA proposed a change to the medical device submission rules whereby all 510k, IDE and PMA submissions will only be accepted electronically; paper copies will no longer be accepted. Since 2013, FDA has accepted eCopies of the paper submission. The applicants were required to prepare at least one fully compiled printed copy of … Read more