[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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