The FDA just released a final rule entitled “Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to Be Required in Electronic Format;” as well as the final guidance document, “eCopy Program for Medical Device Submissions”.
Here, Boudicca discusses the changes associated with this new rule. One major change (which Boudicca is a huge fan of!) is that the FDA will no longer require a paper copy of the entire submission to accompany an electronic copy (eCopy). Only a paper copy of the signed cover letter is required along with one eCopy.
eCopy versus eSubmission
An eCopy is a digital representation of the paper copy of the documents required for FDA review. It includes these minimum documents: the signed cover letter, the premarket review submission cover Sheet form (Form 3514), and the pre-market submission and associated references (as needed). eCopy and electronic submission (eSubmission) both utilize electronic templates and a validator (FDA eSubmitter, https://www.fda.gov/industry/fda-esubmitter). The difference is that an eCopy is created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive, while an eSubmision is submitted through an encrypted portal (or “Gateway”) for the FDA to distribute for review. An eCopy can be considered a static representation of the submission, while an eSubmission can be considered a dynamic representation of the submission. Either method takes advantage of streamlining the submission process and reducing the number of paper copies to review, distribute, file and maintain.
Mandatory versus Voluntary
The following submission types must use the eCopy program:
Although not required, the FDA encourages the use of the eCopy program for these submission types:
… except for:
In the final guidance, formatting of the “root-level” numerical prefixes (0XX_prefix) for non-volume and non-volume-based copies, the use of bookmarks and/or hyperlinks, and Adobe plug-ins (.pdf), .pdf and non-.pdf formats for miscellaneous and statistical files; are the same instructions as previously identified for the “backbone” of the eCopy in the draft guidance from January 2, 2013.
Although there is no maximum total submission size restriction, it is recommended that the total eCopy package does not exceed 1 GB. Larger than 1GB will cause possible delays in the routing process within the FDA Document Control Center.
In the final guidance that was just issued, these are new items:
Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies to Be Required in Electronic Format. 84 FR 2019-27047 available at:Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Required in Electronic Format
“eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff” available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.
For information on eSubmissions produced by the eSubmitter application, refer to FDA eSubmitter page (https://www.fda.gov/industry/fda-esubmitter) and Regulatory Submissions in Electronic Format for Biologic Products (https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/regulatory-submissions-electronic-format-biologic-products).
Food and Drug Administration Draft Guidance: “eCopy Program for Medical Device Submissions” published on January 2, 2013. Superseded by guidance “eCopy Program for Medical Device Submissions” published December 5, 2018 .