[Federal Register Volume 87, Number 118 (Tuesday, June 21, 2022)]
[Notices]
[Pages 36861-36864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13210]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0799]
Improving 510(k) Submission Preparation and Review: Center for
Biologics Evaluation and Research; Voluntary Electronic Submission
Template and Resource Pilot Program; Request for Comments
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Biologics Evaluation and Research (CBER) is announcing a pilot program
for sponsors of CBER premarket notification (510(k)) submissions that
wish to use the voluntary Electronic Submission Template and Resource
(eSTAR) Pilot Program. CBER's voluntary eSTAR Pilot Program is intended
to improve consistency and efficiency in both industry's preparation
and FDA's review of premarket notification (510(k)) submissions. During
CBER's voluntary eSTAR Pilot Program, participants will have the
opportunity to provide input to FDA on the eSTAR Pilot Program for
submissions to CBER.
DATES: FDA is seeking participation in CBER's voluntary eSTAR Pilot
Program beginning June 21, 2022. See section I.A. for instructions on
how to submit a request to participate. The CBER voluntary eSTAR Pilot
Program will select up to nine participants who best match the
selection criteria. This pilot program will begin June 21, 2022. Submit
either electronic or written comments on the notice by August 22, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 22, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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-2022-N-0799 for ``Improving 510(k) Submission Preparation and
Review: Center for Biologics Evaluation and Research; Voluntary
Electronic Submission Template and Resource Pilot Program.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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, 240-402-7500.
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.
[[Page 36862]]
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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
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). FDA 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 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), requires that certain presubmissions and submissions for
devices, including 510(k) submissions, be submitted in such electronic
format as specified in guidance by FDA.
FDA considers both eCopies and eSubmissions to be submissions in
electronic format. eSubmissions are submission packages produced by an
electronic submission template that contains the data of a ``complete''
(see Ref. 4) submission. To support the next step in transition to
510(k) submissions solely in electronic format, FDA has developed
eSTAR, an electronic submission template built within a structured
dynamic PDF that guides a user through construction of an eSubmission.
eSTAR includes the following benefits:
automation (e.g., form construction, autofilling);
content and structure that is complementary to FDA
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. 4)); and
it is free to use.
eSTAR contains the following additional benefits:
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; and
no packaging process.
In February 2020, CDRH piloted the use of the eSTAR electronic
submission template (85 FR 11371). FDA then issued a draft guidance in
September 2021 describing the technical standards associated with
preparation of the electronic submission template for 510(k)s (Ref. 5)
that, when the guidance is finalized, will enable submission of 510(k)
electronic submissions solely in electronic format. In the draft
guidance, FDA noted that CBER also intended to pilot eSTAR. FDA is now
announcing CBER's voluntary eSTAR Pilot Program and soliciting
participation from 510(k) submitters for this program. This pilot will
provide an opportunity for CBER staff to gain experience with review of
and internal processes for 510(k) submissions using the eSTAR template.
It will also provide experience with use of the FDA Electronic
Submissions Gateway for 510(k) submissions using the eSTAR template.
Information collected through the pilot program will help inform FDA on
how to improve eSTAR and identify any additional considerations
specific to submissions for CBER-regulated devices.
A. CBER Voluntary eSTAR Pilot Program Participation
FDA seeks participation from 510(k) submitters in CBER's voluntary
eSTAR Pilot Program beginning June 21, 2022. The CBER voluntary eSTAR
Pilot Program will select up to nine participants whose submissions to
CBER meet the selection criteria.
Companies that may be eligible to participate in CBER's voluntary
eSTAR Pilot Program are limited to those firms following the procedures
set out in section I.B. of this document and that also meet all the
selection criteria that follow:
1. intent to submit a traditional, special, or abbreviated 510(k)
for a medical device regulated by CBER (Ref. 6) using eSTAR within 1
month of acceptance to the CBER voluntary eSTAR Pilot Program; and
2. willingness to provide feedback on eSTAR as outlined in section
I.C. of this document.
At its discretion, FDA may withdraw a manufacturer from the CBER
voluntary eSTAR Pilot Program for not carrying out any of the
commitments mentioned previously.
B. CBER Voluntary eSTAR Pilot Program Procedure
To be considered for CBER's voluntary eSTAR Pilot Program, a
company should submit a statement of interest for participation to
[email protected]. The statement of interest should
include ``CBER Voluntary eSTAR Pilot Program'' in the subject line and
agreement to the selection criteria 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 a CBER regulated device.
The following captures the process for the CBER voluntary eSTAR
Pilot Program:
1. FDA will collect statements of interest for participation in the
pilot program beginning June 21, 2022.
The statement of interest should include:
agreement to the selection criteria listed in section I.A. of
this document
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
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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 eSTAR with participants, as
appropriate.
3. FDA intends to notify the manufacturer via email if the
manufacturer is enrolled as a participant in the CBER's voluntary eSTAR
Pilot Program.
4. The enrolled manufacturer should navigate to the FDA ``Voluntary
eSTAR Program'' web page at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/premarket-submissions and download eSTAR
from the ``Voluntary eSTAR Program'' web page (Ref. 7). Note: eSTAR
should not be submitted to CBER unless the sponsor is a pilot
participant.
5. Directions for preparing and submitting a 510(k) using eSTAR to
FDA are in the final section of the eSTAR pdf. We recommend that all
eSTAR elements including the cover letter be submitted through the FDA
Electronic Submissions Gateway (refer to ``Electronic Submissions
Gateway'') (Ref. 8) or on physical media through CBER's Document
Control Center in accordance with the ``Regulatory Submissions in
Electronic and Paper Format for CBER-Regulated Products'' web page
(Ref. 9). We recommend that you use Adobe Acrobat Pro with eSTAR. Be
aware that eSTARs should not be submitted to CDRH via the Electronic
Submission Gateway, as CDRH does not use the Electronic Submission
Gateway to receive submissions.
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. However, FDA intends to employ a
technical screening process for the eSTAR like the one described in FDA
draft guidance ``Electronic Submission Template for Medical Device
510(k) Submissions'' (Ref. 5). The technical screening process is a
process for verifying that eSTAR responses accurately describe the
device(s) (e.g., there are, in fact, no tissue contacting components if
indicated as such) and that there is at least one relevant attachment
per each applicable attachment-type question (e.g., a Software
Description attachment is included in response to the Software
Description question if software is applicable to the submission). The
technical screening process is anticipated to occur within 15 calendar
days of FDA receiving the 510(k) eSTAR. FDA intends to only begin the
technical screening for 510(k) electronic submissions where the
appropriate user fee has been paid. If the eSTAR is not complete when
submitted, FDA intends to notify the submitter via email and identify
the missing information, and the 510(k) may be placed on hold until a
complete replacement eSTAR is submitted to FDA. The remainder of the
review will be conducted according to the FDA guidance ``The 510(k)
Program: Evaluating Substantial Equivalence in Premarket
Notifications'' (Ref. 10), and the procedures identified in part 807,
subpart E (21 CFR part 807, subpart E).
8. Following completion of the review of 510(k)s in the CBER
voluntary eSTAR Pilot Program, participating manufacturers will have
the opportunity to provide individual feedback on the CBER voluntary
eSTAR Pilot Program through the procedures outlined on the ``Voluntary
eSTAR Program'' web page (Ref. 7). Non-pilot participants are welcome
to submit feedback to the Docket (see ADDRESSES).
During the CBER voluntary eSTAR Pilot Program, CBER staff intends
to be available to answer questions from or concerns of pilot
participants that may arise.
C. Targeted Questions for the CBER Voluntary eSTAR Pilot Program
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?
(6) If applicable, did you experience any difficulties using the
Electronic Submission Gateway to submit eSTAR?
(7) Is eSTAR able to accommodate PDF attachments that are of the
size you typically would provide in a submission?
(8) 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?
(9) 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
part 807, subpart E have been approved under OMB control number 0910-
0120.
III. References
The following references are on display at 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/media/83244/download.
2. ``eCopy Program for Medical Device Submissions: Guidance for
Industry and Food and Drug Administration Staff,'' dated April 27,
2020; available at: https://www.fda.gov/media/83522/download.
3. MDUFA IV Commitment Letter, available at: https://www.fda.gov/media/102699/download.
4. ``Refuse to Accept Policy for 510(k)s: Guidance for Industry and
Food and Drug Administration Staff,'' dated September 13, 2019;
available at: https://www.fda.gov/media/83888/download.
5. ``Electronic Submission Template for Medical Device 510(k)
Submissions: Draft Guidance for Industry and Food and Drug
Administration Staff,'' dated September 29, 2021; available at:
https://www.fda.gov/media/152429/download.
6. Premarket Notification 510(k) Process for CBER-Regulated Products
at: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/premarket-notification-510k-process-cber-regulated-products.
7. Voluntary eSTAR Program, available at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program.
8. Electronic Submission Gateway, available
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at: https://www.fda.gov/industry/electronic-submissions-gateway.
9. Regulatory Submissions in Electronic and Paper Format for CBER-
Regulated Products; available at: https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper-format-cber-regulated-products.
10. ``The 510(k) Program: Evaluating Substantial Equivalence in
Premarket Notifications [510(k)]: Guidance for Industry and Food and
Drug Administration Staff,'' dated July 28, 2014; available at:
https://www.fda.gov/media/82395/download.
Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13210 Filed 6-17-22; 8:45 am]
BILLING CODE 4164-01-P