FDA Final Rule Requires Medical Device Submissions in Electronic Format
Posted December 17, 2019
Effective Jan. 15, 2020, medical device premarket submissions will be required to be sent in electronic format, according to a final rule issued by the Food and Drug Administration (FDA) on Dec. 16.
“We are taking this action to improve the efficiency of FDA’s premarket submission program for medical devices,” wrote the agency in a public notice, while adding that the new rule, which has been published in the Federal Register, would eliminate the need for multiple paper submissions.
In the final rule, the FDA wrote that the electronic submission requirement would “produce cost savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency's ability to review submissions.” It estimated that the “final rule will result in annualized benefits of $1.76 million at a 3 percent discount rate and $1.76 million at a 7 percent discount rate, over 10 years.”
On the same day, a revised version of the guidance document eCopy Program for Medical Device Submission was published to reflect the amended final rule. The FDA defines “eCopy” as “an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. An eCopy is accompanied by a paper copy of the signed cover letter.” Attachment 1 of the document provides extensive guidance on the technical standards for eCopies.
Several other guidance documents also were affected:
- 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 or 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
Questions regarding the amended final rule can be sent to the Division of Industry and Consumer Education (DICE).