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FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “eCopy Program for Medical Device Submissions.” This guidance explains the new eCopy Program for medical device submissions. At this time, submission of an eCopy of a medical device submission is voluntary. However, section 745A(b) of the FD&C Act, added by section 1136 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), requires the submission of an eCopy of certain device submissions after issuance of final guidance. This draft guidance describes how FDA plans to implement the eCopy Program under section 745A(b) of the FD&C Act. The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version.
The eCopy Program is not intended to impact (reduce or increase) the type or amount of data the applicant includes in a submission to support clearance or approval. An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a compact disc, digital video disc, or in another electronic media format that FDA has agreed to accept, accompanied by a copy of the signed cover letter and the complete original paper submission.
In section 745A(b), Congress granted explicit statutory authorization to FDA to implement the statutory eCopy requirement by providing standards, criteria for waivers, and exemptions in guidance. To the extent that this document provides requirements under section 745A(b)(2)(A) of the FD&C Act (i.e., standards, criteria for waivers, and exemptions), indicated by the use of the words
However, this document also contains guidance on implementing the eCopy Program. To the extent that this guidance describes recommendations that are not standards, criteria for waivers, or exemptions under section 745A(b)(2), it is being issued in accordance with FDA's good guidance practices regulation (21 CFR 10.115). Such parts of this guidance, when finalized, will represent the Agency's current thinking on this topic, and do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used for these recommendations if such an approach satisfies the requirements of the applicable statutes and regulations. The use of the word
Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120 (510(k)); the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078 (Investigational Device Exemptions); the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231 (Premarket Approval); the collections of information in section 513(g) of the FD&C Act (21 U.S.C. 360c(g)) have been approved under OMB control number 0910-0705 (513(g)); the collections of information in 21 CFR part 814, subpart H, have been approved under OMB control numbers 0910-0332 and 0910-0661 (Humanitarian Use Devices); and the collections of information in section 564 of the FD&C Act (21 U.S.C. 360bbb-3) have been approved under OMB control number 0910-0595 (Emergency Use Authorization). Prior to implementation of this requirement or issuance of a final guidance on this topic FDA will update the existing OMB approved information collections to properly document the submission of information through both paper and electronic means.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see