4. For what submission types is an eCopy required?
In accordance with Section 745A(b) of the FD&C Act, as added by section 1136 of FDASIA,
and the CDRH guidance on Q-submissions
, an eCopy is required for the following submission
Premarket notification submissions (510(k)s), including third party 510(k)s;
Evaluation of automatic class III designation petitions (de novos);
Premarket approval applications (PMAs), including Transitional PMAs;
Product development protocols (PDPs);
Investigational device exemptions (IDEs) [see partial Exemptions below];
Humanitarian device exemptions (HDEs)
Emergency Use Authorizations (EUAs)
[see Exemptions below];
Certain investigational new drug applications (INDs);
Certain biologics license applications (BLAs);
eCopies for all subsequent submissions to an original submission, including amendments
(amendments include add-to-files, CLIA categorization add-to-files, and appeals), supplements,
and reports (reports include annual/periodic and post-approval reports)
to the submission types
identified above would also be required. Whether it is a single-page submission (i.e., the
company cover letter is the only content) or a multi-volume submission, the eCopy requirements
apply. Although there is no maximum total submission size restriction, it is recommended that
the total package submission not exceed 1 GB to avoid possible load time failures that may delay
the submission process.
“Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food
and Drug Administration Staff” (http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-
This includes all PMA submission types, including, but not limited to, original PMAs, panel-track supplements,
180-day supplements, manufacturing site change supplements, 30-Day Notices, 135-Day Supplements, and post-
approval study supplements and reports, as well as amendments involving changes in the correspondent or
ownership and requests for extensions.
This includes all HDE submission types, including, but not limited to, original HDEs, 180-day supplements,
manufacturing site change supplements, 30-Day Notices, 135-Day Supplements, and post-approval study
supplements and reports, as well as amendments involving changes in the correspondent or ownership and requests
Refer to the guidance entitled, “Emergency Use Authorization of Medical Products”
(http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm) for more information on EUAs.
Applicable only to those devices that are regulated by CBER as biological products under Section 351 of the
Public Health Service (PHS) Act and that also require submission of an IND prior to submission of a BLA. Such
devices are generally those intended for use in screening donated blood for transfusion transmissible diseases.
Applicable only to those devices that are regulated by CBER as biological products under Section 351 of the PHS
Act, including those that do not require submission of an IND prior to the submission of the BLA. Such devices
generally include those reagents used in determining donor/recipient compatibility in transfusion medicine.
Section 745A(b) of the FD&C Act does not apply to Medical Device Reports submitted under 21 CFR Part 803.