On Thursday, September 13th, FDA published a proposed rule which would amend the current premarket submission requirements for medical devices.
In July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, amending the Federal Food, Drug, and Cosmetic (FD&C) Act. The amendments outlined in FDASIA granted FDA with the authority to require the submission of electronic copies (eCopies) for medical device presubmissions, submissions, and any supplements to these presubmissions and submissions.
In January 2013, FDA published a guidance document entitled “eCopy Program for Medical Device Submissions,” marking the beginning of the eCopy program. The Agency updated the eCopy guidance in December 2015, recommending that only one paper copy be submitted, and any additional copies that are required should be submitted as eCopies. In addition, the guidance also outlines other eCopy requirements and “provides instructions for the processing and technical standards for eCopies based on the FDA’s experience with the program.”
Last week the FDA proposed a rule, entitled Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format, would “remove paper and multiple copies and replace them with requirements for a single submission in electronic format.” If finalized, this will improve the efficiency of the medical device premarket submission program by reducing the number of copies required in electronic format.
The proposed rule would affect:
In addition to removing paper submissions, the new rule would also change the regulations that identify FDA’s mailing addresses for submissions. The FDA plans to create a website listing all current mailing addresses. Any changes to these addresses can be added to the website, thus removing the need to issue an amendment to the regulations and simplifying the Agency’s processes. The proposed rule “will remove the mailing addresses for submissions and replace those addresses with a website address for FDA’s CDRH and CBER.
It is important to note that FDA’s eSubmitter program for electronic submissions is different from the submission of an eCopy. An eCopy is an electronic version of your medical device submission and must be mailed to the FDA. The eSubmitter tool allows for submissions to be sent directly via the internet.
FDA believes that the proposed changes will increase its productivity by making the review process more efficient because electronic submissions are available immediately and are much easier to reproduce than paper copies. This proposed rule is open for public comment until December 12, 2018.
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