The US Food and Drug Administration (FDA) intends to remove requirements for paper and multiple copies of medical device premarket applications, and replace it with a single submission in electronic format. The new proposed rule would apply to: 510(k) premarket notifications; Investigational Device Exemptions (IDE); Premarket Approvals (PMA) applications and supplements; Humanitarian Device Exemptions (HDE) and applications to the Center for Biologics Evaluation and Research (CBER). The FDA aims to improve the efficiency of the device premarket submission program by requiring a single electronic submission.
The proposed rule addresses the potential associated with the reproducibility and availability of the data in electronic submissions (eSubmissions), which is aligned with continual work in collaboration with the International Medical Device Regulators Forum.
The change is based on FDA guidance that was issued in 2013, and last updated in 2015, which signified the beginning of the eCopy program for device submissions. Since 1999, medical device sponsors have had the choice of using FDA’s eSubmitter software for transmissions on the Electronic Submission Gateway. However, this software is undergoing fundamental changes for digitisation of global harmonisation efforts.
Although, these eSubmissions differ from eCopies as sponsors are required to mail eCopies to the FDA. The “FDA considers eCopies submissions copied to a CD, DVD, or flash drive and mailed to FDA, and eSubmissions to be submissions in electronic format”.
The proposed rule also includes FDA’s plans to replace mailing addresses with a new website for these to be listed and updated online. This aims to remove the need for the FDA to set forth amendments to current regulations every time addresses need to be updated.
To read more about FDA medical device submissions: amending premarket regulations that require multiple copies and specify paper copies to be allowed in electronic format, please click here.