[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Notices]
[Pages 63837-63839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25494]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1056]
Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``eCopy Program for Medical
Device Submissions.'' The purpose of the draft guidance is to explain
the new electronic copy (eCopy) program for medical device submissions.
The draft guidance describes how FDA plans to implement the eCopy
Program under the Federal Food, Drug, and Cosmetic Act (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. This draft guidance is not final nor is it in effect at this
time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments
[[Page 63838]]
on the draft guidance by November 16, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``eCopy Program for Medical Device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
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 4613, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist the office in processing your
request, or fax your request to CDRH at 301-847-8149. The draft
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
Submit electronic comments on the draft 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: Phil Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678; or Steve 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 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.
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, 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 should in this guidance means that
something is suggested or recommended, but not required. The final
guidance will contain both binding and nonbinding provisions.
III. Electronic Access
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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from the
CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. 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 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.
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.
[[Page 63839]]
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 will be posted to the docket at http://www.regulations.gov.
Dated: October 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-25494 Filed 10-16-12; 8:45 am]
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