Dec 20, 2019

Last year the United States FDA proposed updating existing rules for various types of premarket applications, including 510(k) and premarket approval (PMA) submissions. Instead of requiring medical device manufacturers to submit multiple copies in both paper and electronic formats, the agency was interested in eliminating paper and mandating a single electronic submission.

The FDA has now issued a final rule amending its former requirements in line with the earlier proposal. Paper and multiple copies will no longer be required, and medical device manufacturers are called on to submit one electronic copy of an application. The rule further clarifies that both eCopies (electronic files that are “created and submitted on CD, DVD, or flash drive and mailed to the FDA”) and eSubmissions (files “produce by an electronic submission template” and “transmitted over the internet”) fall under the category of electronic copies.

This rule will take effect on January 15, 2020, 30 days after its publication. It will amend the regulations for the following submission types:

  • Premarket Notification (510(k)) (21 CFR 807.90)
  • Confidentiality of Information Certifications (21 CFR 807.95)
  • Investigational Device Exemption (IDE) (21 CFR 812.20)
  • Premarket Approval (PMA) (21 CFR 814.20)
  • PMA Supplement (21 CFR 814.39)
  • Humanitarian Device Exemption (HDE) (21 CFR 814.104)

According to the proposal, “This action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.” The economic impact analysis that accompanied the final rule states, “The final rule will produce cost-savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency’s ability to review submissions.”

Comments on the original proposal were overwhelmingly positive, with suggestions for further refinements including assigning reference numbers to electronic submissions and requiring submissions to be in eXtensible Markup Language (XML) format. The FDA noted that the language of the rule permits the use of structured data formats but does not make their use mandatory. None of the submitted comments led to a change in the final rule.

Related US FDA regulatory information from Emergo:


  • Timothy Herr