[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.

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    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