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FDA Proposing to Amend Medical Device Premarket Regulations to Remove Paper and Multiple Copies and Replace them with Requirements for a Single Submission in Electronic Format

September 24, 2018

FDA Proposing to Amend Medical Device Premarket Regulations to Remove Paper and Multiple Copies and Replace them with Requirements for a Single Submission in Electronic Format (proposed Rule)

Executive Summary

The US FDA has proposed to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. If finalized, this action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA’s premarket submission program for medical devices.

Because a medical device premarket submission in electronic format is easily reproducible, and the requirement for multiple copies, whether in electronic format or paper form, is no longer necessary, FDA believes it is beneficial to the public to limit any burden and expense to submitters caused by requiring additional copies.

This FDA proposal aimed at revising regulations for devices to remove the requirements for multiple copies of submissions and to instead require one electronic version affect the following submission:

  • Premarket notification submissions (510(k) submissions) (21 CFR 807.90), including confidentiality of information certification (21 CFR 807.95);
  • Investigational device exemption applications (21 CFR 812.20);
  • Premarket approval applications (PMA) (21 CFR 814.20), including PMA supplements (21 CFR 814.39); and
  • Humanitarian device exemption applications (21 CFR 814.104).
  • Also, submissions for Center for Biologics Evaluation and Research (CBER) regulated devices.

The submission of an eCopy is separate and distinct from FDA’s electronic submission programs (eSubmitter), which include the Electronic Submission Gateway (ESG) and CDRH’s 510(k) eSubmissions Pilot Program (79 FR 24732, May 1, 2014). Nevertheless, FDA considers both to be submissions in electronic format. While eCopy provides for submissions to be in electronic format, the eCopy submissions must still be mailed to FDA. By contrast, eSubmitter allows for electronic submissions to be transmitted over the internet. FDA has been moving toward transforming all regulatory submissions from mailed copies to electronic means via the internet. Since January 1999, FDA has accepted voluntary electronic submissions through eSubmitter. FDA presently utilizes the ESG for the receipt and processing of many types of electronic regulatory submissions.

FDA considers “electronic format” for premarket submissions to include eCopy submissions provided via:

  • CD, DVD, or flash drive/USB and mailed to FDA, and
  • eSubmissions, to be submissions in electronic format.

Proposed Effective Date

FDA is proposing that any final rule based on this proposal become effective 30 days after the date of publication of a final rule in the Federal Register.

Summary of Costs and Benefits

The amendment would produce cost savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency’s ability to review submissions. Firms would incur minimal administrative costs to read and understand the rule. FDA expect the economic impact of this regulation to be a total net costs savings yielding positive net benefits.

FDA stated that the proposed rule would result in annualized net benefits in the form of cost savings of around $2.80 million with a 3 percent discount rate and $2.71 million with a 7 percent discount rate.