Guidance fda ecopy software

A submission with an ecopy that does not meet the technical standards outlined in the ecopy guidance will be placed on ecopy hold until a. The fda guidance on ecopy describes the specifications of the electronic files mostly pdf files in terms of the size of the file, the split into multiple files, file naming rules, and media on which to copy the files for submission. This blog summarizes the changes in fda policy which was released on december 16, 2019 as a new ecopy guidance for device manufacturers. The purpose of this guidance is to explain the new electronic copy ecopy program for medical device submissions. The first part of the guidance describes the ecopy program and attachment 1 of the guidance describes the technical standards. On december 31, 2012, fda issued a final guidance document entitled ecopy program for medical device submissions ecopy guidance.

A submission with an ecopy that does not meet the technical standards outlined in the ecopy guidance will be placed on ecopy. A handful of new guidance documents released by the fda on tuesday aim to pave the way for medical device innovation by allowing developers to make iterative changes to. Refer to the ecopy guidance entitled ecopy program for medical device submissions for details, including the technical standards for ecopies. Final guidance fda2012d1056 ecopy program for medical device. Food and drug administration center for devices and. No more paper all medical device submission to fda to be.

The food and drug administration has issued draft guidance on clinical decision support software for healthcare providers to clarify what types of systems will no longer be defined as medical. This is an updated version of the guidance that was issued on october 10, 20. To assist applicants in meeting ecopy requirements. Fda finalizes new guidance to support medical device. This is an updated version of the guidance that was issued on december 31, 2012. The us food and drug administration has provided further guidance for its ecopy program for medical device registration submissions. Save the installation zip file to your computer and extract the jinstall. You can and should continue to use the ecopy validation software module provided by the fda to ensure that your ecopy will properly upload.

The purpose of this guidance is to explain the ecopy program for medical device submissions. To download the fda esubmitter software, click on the following link. Fda issues draft guidance on decision support software. All inquiries about ecopys now must go to we thank you for your. Under the new rule, the paper copy will be eliminated and the ecopy will become the only copy sent to the fda. It provides clarification to the processing and technical standards for ecopies based on fda s experience to date with the program. Refer to the ecopy guidance entitled ecopy program for medical device submissions for details. Fda issues final guidance documents on fdas ecopy program. Updated guidance on us fda ecopy program for medical device. An electronic copy ecopy is defined as an exact duplicate of the paper submission, created and submitted on a cd, dvd or other electronic. This guidance explains the ecopy program for medical device submissions as well as implementation of this program by the fda. It provides clarification to the processing and technical standards for ecopies based on fda s experience to date.