[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24732-24734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09912]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0366]


Pilot Program for Center for Devices and Radiological Health 
Electronic Submission of Premarket Notification Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) Center for Devices and 
Radiological Health (CDRH) is announcing the availability of a CDRH 
eSubmissions Pilot Program (eSubmissions Pilot), which will be a new 
pathway that will guide the user through constructing and submitting 
their 510(k) submissions electronically without the requirement for 
submitting a hard copy or a compact disc. Participation in the 
eSubmissions Pilot is open to applicants whose device submissions would 
be reviewed in either of two branches in CDRH's Office of Device 
Evaluation (ODE), the Cardiac Diagnostic Devices Branch and the 
Peripheral Interventional Devices Branch, and is limited to unbundled, 
traditional 510(k) submissions for classified devices only. The 
eSubmissions Pilot will use the existing eSubmitter software for data 
acquisition and the existing Electronic Submission Gateway (ESG) for 
submitting (the eSubmissions Pilot is not intended to evaluate the 
existing eSubmitter software or the existing ESG). The eSubmissions 
Pilot is intended to provide industry and CDRH staff the opportunity to 
evaluate the 510(k) eSubmission with regards to the content (wording of 
questions, help text and guides), layout, and flow of the questions.

DATES: FDA will begin accepting requests to participate in the 
eSubmissions Pilot immediately. See the ``Procedures'' section for 
instructions on how to submit a request.

FOR FURTHER INFORMATION CONTACT: Patrick Axtell, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1566, Silver Spring, MD 20993-0002, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has been moving toward transforming all regulatory submissions 
from paper to electronic methods. Since January 1999, FDA has accepted 
voluntary electronic submissions for certain types of regulatory 
submissions. FDA presently utilizes eSubmitter as a platform for 
submitting many types of submissions across several Centers. The 
eSubmitter platform contains templates for many types of submissions 
specific to those Centers and any template can be chosen by the user 
for constructing and submitting the appropriate type of submission. The 
510(k) eSubmission program introduces a new template in eSubmitter for 
use in submitting 510(k)s to ODE.
    FDA presently utilizes the ESG for the receipt and processing of 
many types of electronic regulatory submissions (http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm). The ESG 
automates the receipt, acknowledgment, routing and notification of 
electronic submissions via the Internet and meets FDAs standards of 
electronic information exchange.
    The benefits to industry of this pilot program include, but are not 
limited to:

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     Application of the ``Refuse to Accept Policy for 510(k)s'' 
(RTA) guidance document will be waived during the pilot (i.e., no 
submissions submitted via the software will be subject to an acceptance 
review as outlined in the RTA guidance).
     A guided interface that leads the sponsor through the 
process of constructing and submitting their 510(k) submissions. Built 
into the software are a number of features that ensure appropriate 
regulatory submission standards and recommendations are met or 
considered. Further, software features will prompt the inclusion of 
information that will avert some of the common procedural and 
administrative issues reviewers find during their reviews.
     The 510(k) eSubmissions are expected to decrease both the 
time spent by industry creating and submitting the 510(k).
     The 510(k) eSubmission process may also reduce the number 
of questions asked by FDA to which the applicant must officially 
respond.
     Since the 510(k) submission process will be completely 
electronic, time will not be lost in physical transit of the submission 
to FDA.
     The eSubmission software is intended to be a guide for 
users to instruct them as to what is required and recommended when 
submitting a 510(k), and will act as an aid for learning about the 
process. The use of electronic signatures will allow sponsors to 
legally sign documents without the need for printing, scanning and 
uploading.
    The benefits to FDA include, but are not limited to:
     A reduction in required resources and time spent in 
processing the submission for review.
     Easier and faster reviews due to a standardized submission 
structure.
    510(k) eSubmissions also support the Secretary's health IT 
priorities to harness information technology to improve health care and 
patient safety. The information learned and experiences gained from the 
eSubmissions Pilot will be used to optimize the process by which data 
and documents are obtained and ensure that the software infrastructure 
functions properly and electronic signatures work as intended.

II. CDRH eSubmissions Pilot

    The eSubmissions Pilot presents a voluntary process to interested 
sponsors. This notice outlines: (1) The guiding principles underlying 
the eSubmissions Pilot; (2) the scope of the eSubmissions Pilot; and 
(3) the procedures CDRH intends to follow for the eSubmissions Pilot. 
The eSubmission process works similarly to commercially available tax 
preparation software packages such that it guides the sponsor through 
the submission process. Help text, links, embedded guides, and other 
aids are intended to assist the user and allow novice 510(k) submitters 
to navigate through the process of submitting a 510(k) submission. The 
software will consist of textual suggestions and questions designed to 
obtain all of the data FDA needs to review the submission and ensure no 
required data are omitted. FDA intends to collect data via text fields, 
checkboxes, dropdown menus, and, where it would be burdensome to 
collect data via these methods, file attachments. For example, FDA 
intends to collect much of the administrative data as well as basic 
information, such as the Indications for Use, via the software 
interface, not via file attachments. However, instruction manuals, 
software documentation, performance testing and other large documents 
may be attached.

A. Guiding Principles

    The following basic principles underline the eSubmissions Pilot 
described in this document. CDRH intends that these principles create a 
common understanding between the sponsor and CDRH about the goals and 
parameters of the eSubmissions Pilot:
    1. FDA believes the use of the eSubmission process will result in 
administratively complete 510(k) submissions and will not be conducting 
a separate acceptance review for the files submitted through the 
eSubmissions Pilot.
    2. The eSubmission will serve as the only submission required; no 
other copies of the submission will be required.
    3. The submission of Amendments and Supplements needs to be 
completed through the software during the eSubmissions Pilot. FDA 
encourages sponsor and reviewer interaction during the review process.
    4. FDA will not publicly disclose participation of a sponsor in the 
eSubmissions Pilot, unless the sponsor consents or has already made 
this information public, or disclosure is required by law.
    5. Participating in this eSubmissions Pilot does not guarantee 
clearance of a sponsor's 510(k) submission, nor is a sponsor precluded 
from withdrawing from the eSubmissions Pilot and pursuing a 
conventional 510(k)s submission and review through the current pathway.
    6. Due to FDA resource issues, FDA intends to limit the 
eSubmissions Pilot to approximately 50 to 100 submissions. FDA may 
further limit the number of submissions from an individual firm as 
resources and eSubmissions Pilot needs allow.
    7. An Extensible Markup Language (XML) Schema Definition (XSD) for 
the eSubmissions Pilot template was produced, and FDA intends to allow 
future submissions using alternative approaches to eSubmitter (e.g., 
via proprietary software purchased or produced by a medical device 
firm), as long as the submission is compliant with the XSD. If FDA 
commits to also receiving Regulated Product Submissions (RPS) in the 
future, FDA intends to expand this method of receipt to accept RPS 
packages. In addition, a different, more modern platform may be used 
for future eSubmissions other than eSubmitter.

B. Scope of eSubmissions Pilot

    Voluntary participation in the eSubmissions Pilot is open to 
sponsors whose submissions are reviewed in ODE's Division of 
Cardiovascular Devices Cardiac Diagnostic Devices Branch or Peripheral 
Interventional Devices Branch. We encourage 510(k) sponsors of all 
device types, including those reviewed in other branches, to review the 
software interface and provide feedback via http://www.regulations.gov 
or the Division of Dockets Management (see Comments). The eSubmissions 
Pilot is limited to unbundled, traditional 510(k) submissions for 
classified devices only.\1\
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    \1\ We are not accepting third party 510(k)s or Combination 
Products in the eSubmissions Pilot at this time.
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C. Procedures

    The following procedures have been developed to manage the CDRH 
eSubmissions Pilot effectively:
    1. Under the eSubmissions Pilot, 510(k) submissions will be 
reviewed according to CDRH standard procedures.
    2. eSubmission will be available for use and submission 24 hours a 
day and 7 days a week. However, if a 510(k) is received outside of 
normal business hours (Monday to Friday, 8 a.m. to 4:30 p.m. excluding 
Federal holidays or dates the Federal Government is shutdown), the 
submission receipt date will be considered the next business day.
    3. Participation in the eSubmissions Pilot does not affect 
submission user fee obligations. If the required user fee is not paid 
at the time of submission, the

[[Page 24734]]

receipt date will be the receipt date of a complete User Fee Coversheet 
via eSubmission. If a User Fee Coversheet is submitted outside of 
normal business hours (Monday to Friday, 8 a.m. to 4:30 p.m. excluding 
Federal holidays or dates the Federal Government is shutdown), the User 
Fee Coversheet receipt date will be considered the next business day.
    4. Volunteers interested in participating in the CDRH 510(k) 
eSubmissions Pilot should contact eSubmissions Pilot staff by email at 
[email protected]. This email address should also be used to report 
issues and ask questions. General feedback and comments about the 
eSubmissions Pilot, 510(k) template, and process can be provided via 
http://www.regulations.gov or the Division of Dockets Management (see 
Comments).
    5. Additional information on the CDRH 510(k) eSubmissions Pilot is 
available at http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm221506.htm.

III. Duration of the eSubmissions Pilot

    FDA intends to accept requests for participation in the 
eSubmissions Pilot through September 30, 2014, or as resources and 
eSubmissions Pilot needs allow. Modifications to the CDRH 510(k) 
eSubmissions Pilot will be made available at http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm221506.htm to all eSubmissions Pilot 
participants and stakeholders.

IV. Comments

    Interested persons may submit electronic comments regarding the 
eSubmissions Pilot for CDRH Electronic Submission of Premarket 
Notification Submissions to http://www.regulations.gov or written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 will be posted to 
the docket at http://www.regulations.gov.

    Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09912 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P