FDA moves to electronic-only device submissions

LabPulse.com staff writers
Dec 12, 2019
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The U.S. Food and Drug Administration (FDA) now requires medical device premarket submissions to be sent electronically, eliminating the need for multiple paper submissions.

The rule, which aims to improve the agency's efficiency, was issued on December 13. The administration plans to publish a revised "eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff," which will reflect the amendments to the regulations.

Additionally, the FDA plans to update the following other guideance documents to conform with the change:

  • Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
  • Real-Time Premarket Approval Application (PMA) Supplements
  • 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method for Process Changes
  • Annual Reports for Approved Premarket Approval Applications (PMA)
  • FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

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