Newsletter - September 13, 2018
No More Paper: All Medical Device Submission to FDA to be Electronic Only
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....Read More
OIG Tells FDA to Make Cybersecurity Concerns a Criterion for RTF
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. Read More
No More Paper: All Medical Device Submission to FDA to be Electronic Only
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....Read More
OIG Tells FDA to Make Cybersecurity Concerns a Criterion for RTF
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. Read More
