[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Notices]
[Pages 102-104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31478]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1056]


Guidance for Industry and Food and Drug Administration Staff; 
eCopy Program for Medical Device Submissions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``eCopy Program for Medical 
Device Submissions.'' The purpose of the guidance is to explain the new 
electronic copy (eCopy) Program for medical device submissions, which 
is intended 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 guidance describes 
how FDA has implemented the eCopy Program under the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act). This guidance also provides the 
standards for a valid eCopy under the FD&C Act and identifies the 
submission types that must include an eCopy in accordance with these 
standards for the submission to be processed and accepted for review by 
FDA. This final guidance will be considered in effect on January 1, 
2013, or at the time of publication, whichever is later.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``eCopy Program for Medical Device Submissions'' to 
the Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver 
Spring, MD 20993-0002. Send

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one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Samie Allen, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1533, Silver 
Spring, MD 20993-0002, 301-796-6055; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
and FDA staff entitled ``eCopy Program for Medical Device 
Submissions.'' This guidance explains the new eCopy Program for medical 
device submissions. This final guidance will be considered in effect on 
January 1, 2013, or at the time of publication, whichever is later. 
After this date, submission of an eCopy for a medical device submission 
is no longer voluntary. 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 guidance 
describes how FDA has implemented 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 flash drive, accompanied by a copy of the 
signed cover letter and the complete paper submission.
    In the Federal Register of October 17, 2012 (77 FR 63837), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by November 16, 2012. Eight comments 
were received and in general were supportive of the eCopy Program. 
However, the comments contained multiple recommendations pertaining to 
the organization of the guidance and requests for clarification on 
details such as how many copies are needed for each submission type, 
for what types of submissions an eCopy is required, the necessity for a 
signed cover letter, how eCopy processing is conducted, when a 
submission begins the review process, and how to interpret some of the 
standards in the Attachment. In response to these comments, FDA revised 
the guidance document to clarify the primary points of confusion 
identified, and restructured the information for better readability.

II. Significance of Guidance

    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 must or required, 
this document is not subject to the usual restrictions in FDA's good 
guidance practice regulations, such as the requirement that guidances 
not establish legally enforceable responsibilities. (See 21 CFR 
10.115(d).)
    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 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 should in this guidance means that something is suggested or 
recommended, but not required. This final guidance contains both 
binding and nonbinding provisions.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``eCopy Program for Medical Device Submissions,'' you may either send 
an email request to [email protected] to receive an electronic copy of 
the document or send a fax request to 301-847-8149 to receive a hard 
copy. Please use the document number 1797 to identify the guidance you 
are requesting.

IV. Paperwork Reduction Act of 1995

    This 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).

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and

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will be posted to the docket at http://www.regulations.gov.

    Dated: December 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31478 Filed 12-31-12; 8:45 am]
BILLING CODE 4160-01-P