Notice2023-06374
Soft (Hydrophilic) Daily Wear Contact Lenses-Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
March 28, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Soft (Hydrophilic) Daily Wear Contact Lenses--Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff." The device-specific guidance identified in this notice was developed in accordance with the final guidance entitled "Safety and Performance Based Pathway."
Full Text
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<title>Federal Register, Volume 88 Issue 59 (Tuesday, March 28, 2023)</title>
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[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18319-18321]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06374]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-4843]
Soft (Hydrophilic) Daily Wear Contact Lenses--Performance
Criteria for Safety and Performance Based Pathway; Guidance for
Industry and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Soft (Hydrophilic)
Daily Wear Contact Lenses--Performance Criteria for Safety and
Performance Based Pathway; Guidance for Industry and Food and Drug
Administration Staff.'' The device-specific guidance identified in this
notice was developed in accordance with the final guidance entitled
``Safety and Performance Based Pathway.''
DATES: The announcement of the guidance is published in the Federal
Register on March 28, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2019-D-4843 for ``Soft (Hydrophilic) Daily Wear Contact Lenses--
Performance Criteria for Safety and Performance Based Pathway; Guidance
for Industry and Food and Drug Administration Staff.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
[[Page 18320]]
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Soft (Hydrophilic) Daily Wear Contact Lenses--Performance Criteria
for Safety and Performance Based Pathway; Guidance for Industry and
Food and Drug Administration Staff'' to the Office of Policy, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.
FOR FURTHER INFORMATION CONTACT: Jason Ryans, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-4908.
SUPPLEMENTARY INFORMATION:
I. Background
This device-specific guidance document provides performance
criteria for premarket notification (510(k)) submissions to support the
optional Safety and Performance Based Pathway, as described in the
guidance entitled ``Safety and Performance Based Pathway.'' \1\ As
described in that guidance, substantial equivalence is rooted in
comparisons between new devices and predicate devices. However, the
Federal Food, Drug, and Cosmetic Act does not preclude FDA from using
performance criteria to facilitate this comparison. If a legally
marketed device performs at certain levels relevant to its safety and
effectiveness, and a new device meets those levels of performance for
the same characteristics, FDA could find the new device as safe and
effective as the legally marketed device. Instead of reviewing data
from direct comparison testing between the two devices, FDA could
support a finding of substantial equivalence with data demonstrating
the new device meets the level of performance of an appropriate
predicate device(s). Under this optional Safety and Performance Based
Pathway, a submitter could satisfy the requirement to compare its
device with a legally marketed device by, among other things,
independently demonstrating that the device's performance meets
performance criteria as established in the above-listed guidance,
rather than using direct predicate comparison testing for some of the
performance characteristics.
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\1\ Available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway</a>.
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A notice of availability of the draft guidance appeared in the
Federal Register of March 4, 2020 (85 FR 12788). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including clarifying the recommended contact lens
thickness for spectral transmittance and ultraviolet transmittance
performance testing. Additionally, clarification has been included to
describe how this guidance relates to FDA's special controls guidance
document entitled ``Premarket Notification [510(k)] Guidance Document
for Class II Daily Wear Contact Lenses.'' \2\
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\2\ Available at: <a href="https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-daily-wear-contact-lenses-premarket-notification-510k-guidance-document">https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-daily-wear-contact-lenses-premarket-notification-510k-guidance-document</a>
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This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Soft (Hydrophilic) Daily Wear Contact
Lenses.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``Soft (Hydrophilic) Daily Wear Contact
Lenses--Performance Criteria for Safety and Performance Based Pathway;
Guidance for Industry and Food and Drug Administration Staff'' may send
an email request to <a href="/cdn-cgi/l/email-protection#b9fafdebf194feccd0ddd8d7dadcf9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="387b7c6a70157f4d515c59565b5d785e5c591650504b165f574e">[email protected]</span></a> to receive an electronic
copy of the document. Please use the document number GUI00019022 and
complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:
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OMB control
21 CFR part; guidance; or FDA form Topic No.
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807, subpart E.................... Premarket 0910-0120
notification.
``Requests for Feedback on Medical Q-submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff''.
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[[Page 18321]]
Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06374 Filed 3-27-23; 8:45 am]
BILLING CODE 4164-01-P
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