[Federal Register Volume 85, Number 39 (Thursday, February 27, 2020)]
[Notices]
[Pages 11371-11373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0625]


Improving 510(k) Submission Preparation and Review: Voluntary 
Electronic Submission Template and Resource Pilot Program; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Devices and Radiological Health (CDRH or Center) is announcing its 
voluntary Electronic Submission Template and Resource (eSTAR) Pilot 
Program. The eSTAR Pilot Program is voluntary and intends to improve 
consistency and efficiency in both industry's preparation and FDA's 
review of premarket notification (510(k)) submissions. During the 
voluntary eSTAR Pilot Program, pilot participants will have the 
opportunity to provide input to FDA on eSTAR.

DATES: FDA is seeking participation in the voluntary eSTAR Pilot 
Program beginning February 27, 2020. See section I.A. for instructions 
on how to submit a request to participate. The voluntary eSTAR Pilot 
Program will select up to nine participants who best match the 
selection criteria. This pilot program will begin February 27, 2020.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-N-0625 for ``Voluntary eSTAR Pilot Program.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jacqueline Gertz, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993, 240-402-
9677, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Medical Device User Fee Amendments of 2012 (MDUFA III) 
Commitment Letter from the Secretary of Health and Human Services to 
Congress, FDA committed to streamlining review processes by moving 
beyond paper-based review (Ref. 1). Under section 745A(b) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1), 
added by section 1136 of the Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-144), an electronic copy (eCopy) is 
required for certain premarket submission types, including 510(k) 
submissions. FDA provided additional information about the submissions 
subject to the eCopy requirements in section 745A(b) of the FD&C Act 
and recommendations about the use of eCopy generally in a guidance 
initially issued in 2013 (Ref. 2), and subsequently published a final 
rule in the Federal Register of December 16, 2019 (84 FR 68334) 
amending FDA's regulations, where appropriate, to reflect the 
requirement of a single submission in electronic format, including the 
use of eCopy requirements.
    In the Medical Device User Fee Amendments of 2017 (MDUFA IV) 
Commitment Letter from the Secretary of Health and Human Services to 
Congress (Ref. 3), FDA committed to developing ``electronic submission 
templates that will serve as guided

[[Page 11372]]

submission preparation tools for industry to improve submission 
consistency and enhance efficiency in the review process.'' In 
addition, section 745A(b) of the FD&C Act, as amended by section 207 of 
the FDA Reauthorization Act of 2017 (Pub. L. 115-52), also requires 
that presubmissions and submissions for devices, including 510(k) 
submissions, be submitted in such electronic format as specified in 
guidance by FDA.
    eCopies are an electronic version of a medical device submission 
created and submitted on a CD, DVD, or flash drive. eSubmissions are 
submission packages produced by an electronic submission template 
(e.g., eSubmitter, eSTAR) that contains all the structured and 
unstructured data of a complete submission. FDA considers both eCopies 
and eSubmissions to be submissions in electronic format.
    As a first step in the transition to submissions solely in 
electronic format, FDA used the eSubmitter platform to develop an 
electronic submission template for 510(k) submissions. It is a free 
tool, and its use is optional. The eSubmitter application includes an 
electronic submission template that is a collection of questions, text, 
logic, and prompts that guides a user through preparation of a 510(k) 
submission. Upon completion, the resulting submission package contains 
all the structured and unstructured data of a complete 510(k) 
submission. This platform and submission process is currently being 
piloted through the ``Quality in 510(k) Review Program Pilot'' (Ref. 4) 
for the submission of traditional and abbreviated 510(k)s for devices 
that are reviewed by CDRH and fall under selected product codes.
    Based on the experience with the eSubmitter platform, FDA has 
developed eSTAR, which includes similar benefits as eSubmitter, as well 
as additional benefits. Similar to eSubmitter, eSTAR includes the 
following benefits: Automation (e.g., form construction, autofilling); 
content and structure that is complementary to CDRH internal review 
templates; integration of multiple resources (e.g., guidances, 
databases); guided construction for each submission section; automatic 
verification (i.e., FDA does not intend to conduct a Refuse to Accept 
(RTA) review (Ref. 5); and it is free to use. In comparison to 
eSubmitter, eSTAR contains the following additional benefits:

 More intuitive interface
 no special software installation (if the user has Adobe 
Acrobat or similar software already installed)
 support for images and dynamic pop-up messages
 mobile device and Apple iOS support
 ability to comment when converted to a static PDF
 ability to share (e.g., email) an eSTAR file that is in the 
process of being constructed
 no necessary packaging process

    FDA is announcing and soliciting participation from 510(k) 
submitters for the voluntary eSTAR Pilot Program. Data collected 
through the pilot program will help inform FDA on how to improve eSTAR.

A. Voluntary eSTAR Pilot Program Participation

    FDA seeks participation in the voluntary eSTAR Pilot Program 
beginning February 27, 2020. The voluntary eSTAR Pilot Program will 
select up to nine participants who provide a holistic representation of 
the medical device industry and meet the selection criteria.
    Companies that may be eligible to participate in this voluntary 
eSTAR Pilot Program are limited to those firms following the procedures 
set out in section I.B and that also meet all the selection qualities 
that follow:
    1. Intent to submit a traditional, special, or abbreviated 510(k) 
for a medical device (not a combination product) using eSTAR within 3 
months of acceptance to the voluntary eSTAR Pilot Program;
    2. willing to provide feedback on eSTAR as outlined in section I.C. 
of this document; and
    3. intent to submit at least one 510(k) for a device that contacts 
body tissue and includes software.
    At its discretion, FDA may withdraw a manufacturer from the 
voluntary eSTAR Pilot Program for not carrying out any of the 
commitments mentioned previously.

B. Procedure

    To be considered for the voluntary eSTAR Pilot Program, a company 
should submit a statement of interest for participation to 
[email protected]. The statement of interest should include 
agreement to the selection qualities listed in section I.A. of this 
document, as well as a description of the device in enough detail to 
allow verification that it is not a combination product, and that it is 
a software enabled tissue contacting device.
    The following captures the proposed process for the voluntary eSTAR 
Pilot Program:
    1. FDA will collect statements of interest for participation in the 
pilot program beginning February 27, 2020.
    The statement of interest should include:

 Agreement to the selection qualities listed in section I.A of 
this document
 the size of the company by specifying the number of personnel 
and the amount of revenue per year
 the device(s) that is/are likely to be submitted during the 
pilot program using eSTAR

    2. FDA will select no more than nine participants, who best meet 
the selection criteria and who reflect the broad spectrum of device 
manufacturers, including companies that develop a range of products. 
Enrollment in the pilot program will be ongoing throughout the duration 
of the program. FDA will apply lessons learned from the initial 
participants in the pilot program to refine the eSTAR tool with 
participants.
    3. FDA intends to notify the manufacturer via email if the 
manufacturer is enrolled as a participant in the voluntary eSTAR Pilot 
Program.
    4. The enrolled manufacturer should download eSTAR from the 
following website: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-program-pilots. Note: eSTAR should not be 
submitted to FDA unless the sponsor is a pilot participant.
    5. Directions for preparing and submitting an eSTAR to FDA are in 
the final section of the eSTAR pdf. We recommend that you use Adobe 
Acrobat with eSTAR.
    6. If eligible and enrolled as a participant, the manufacturer 
should submit a 510(k) submission prepared and verified using eSTAR 
within the timeframe identified in the selection criteria in section 
I.A. of this document.
    7. Once the eSTAR-prepared 510(k) is received by FDA, FDA does not 
intend to conduct the RTA process. The remainder of the procedure will 
be conducted according to the FDA guidance ``The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications'' (Ref. 
6) and the procedures identified in 21 CFR part 807, subpart E. 
However, if the contents of any attachment or text field are irrelevant 
to the purpose of the attachment or text field (e.g., the Device 
Description attachment does not contain any descriptive information 
about the device) we may put your submission on hold, and request this 
particular information only, before beginning a comprehensive review.
    8. Following completion of the review of 510(k)s in the voluntary 
eSTAR Pilot Program, participating manufacturers will have the 
opportunity to provide individual feedback on the voluntary

[[Page 11373]]

eSTAR Pilot Program through the procedures outlined on the voluntary 
eSTAR Pilot Program website. Non-pilot participants are welcome to 
submit feedback to the Docket (see ADDRESSES).
    During the voluntary eSTAR Pilot Program, CDRH staff intends to be 
available to answer questions or concerns that may arise.

C. Targeted Questions

    FDA requests responses to the following questions about eSTAR from 
pilot program participants and stakeholders outside the pilot who want 
to submit comments to the docket.
    (1) Is eSTAR able to integrate into your organization's business 
process?
    (2) Are you able to open eSTAR, and are you able to add values to 
the structured data fields, as well as add attachments? Once entered 
and added, are the data retained after closing and reopening eSTAR?
    (3) If you use Assistive Technology, are you able to navigate 
through and complete eSTAR?
    (4) If eSTAR is not intuitive to use, why?
    (5) Is the organization and content in eSTAR as expected, or do you 
have suggestions for improvement?
    (6) Is eSTAR able to accommodate PDF attachments that are of the 
size you typically would provide in a submission?
    (7) If all the required questions (indicated by red or green 
indicators) are provided values, and all the required attachments are 
added, does eSTAR properly indicate it is complete on the first page, 
and are all the sections listed in the ``Completed'' column in the 
final section?
    (8) Do you have any suggestions to improve the effectiveness of 
eSTAR in its purpose, or suggestions to improve the usability?

II. Paperwork Reduction Act of 1995

    This notice refers to previously approved FDA collections of 
information. 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. 3501-3521). The collections of information in 21 
CFR part 807, subpart E have been approved under OMB control number 
0910-0120.

III. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES), and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. MDUFA III Commitment Letter, available at: https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
2. FDA Guidance for Industry and FDA Staff ``eCopy Program for 
Medical Device Submissions,'' dated October 10, 2013. This document 
was superseded by the guidance of the same title dated December 16, 
2019, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.
3. MDUFA IV Commitment Letter, available at: https://www.fda.gov/media/102699/download.
4. Quality in 510(k) Review Program Pilot, available at: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-program-pilots#quik.
5. FDA Guidance for Industry and FDA Staff ``Refuse to Accept Policy 
for 510(k)s,'' dated September 13, 2019, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks.
6. FDA Guidance for Industry and FDA Staff ``The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications 
[510(k)],'' dated July 28, 2014, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k.

    Dated: February 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03945 Filed 2-26-20; 8:45 am]
BILLING CODE 4164-01-P