Patient-Matched Guides to Orthopedic Implants; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 41967-41969 [2023-13730]

Download as PDF Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002; or the Policy and Regulations Staff (HFV– 6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Christine Bradshaw, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993–0002, 301– 796–1200, CDER-OPDP-RPM@ fda.hhs.gov; Diane Maloney, 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; or Kathryn Dennehy, Center for Veterinary Medicine (HFV– 245), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301–837–7554, Kathryn.Dennehy@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with NOTICES1 I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.’’ This guidance describes recommendations for how firms including quantitative efficacy or risk information about their drugs 1 in DTC promotional communications can make the language and presentation more consumer-friendly. While this guidance focuses on quantitative presentations of efficacy and risk information, firms may wish to refer to these principles and recommendations for quantitative presentations of other product benefits (keeping in mind that any such presentation of other product benefits must comply with applicable statutory and regulatory requirements). When describing efficacy and risk information about a drug in promotional communications, firms generally have flexibility regarding how they present this information as long as the presentation is not false or misleading and complies with other applicable statutory and regulatory requirements. FDA understands that firms may experience challenges when 1 The term ‘‘drugs’’ in the guidance refers to prescription human drug and biological products and to prescription and OTC animal drugs. VerDate Sep<11>2014 18:48 Jun 27, 2023 Jkt 259001 determining how to present quantitative efficacy or risk information in their DTC promotional communications so that consumers have an opportunity to attend to, understand, and use the information to form accurate perceptions about their drugs. Therefore, FDA is issuing this guidance to provide recommendations for presenting quantitative efficacy and risk information in DTC promotional communications and to encourage firms to follow these recommendations when including such information in their DTC promotional communications. The guidance covers the following topics for presenting quantitative efficacy and risk information in DTC promotional communications, based on current research findings related to communicating health information: • Providing quantitative efficacy or risk information for the control group, when applicable; • Presenting probability information in terms of absolute frequencies, percentages, and relative frequencies; • Formatting quantitative efficacy or risk information; and • Using visual aids to illustrate quantitative efficacy or risk information. This guidance finalizes the draft guidance entitled ‘‘Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements’’ issued on October 17, 2018 (83 FR 52484). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include clarifying considerations for quantitative efficacy or risk presentations across various media types and providing additional explanations regarding specific concepts and examples that were included in the draft guidance. In addition, editorial and organizational changes were made to improve clarity. 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 ‘‘Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.’’ 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. Paperwork Reduction Act of 1995 This guidance document recommends information collection activity subject to review and approval by the Office of PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 41967 Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). Burden that may be attributable to recommendations for presenting quantitative efficacy and risk information in direct-to-consumer promotional labeling and advertisements as discussed in Section III of the guidance document is approved under OMB control number 0910–0686. The guidance document also refers to previously approved FDA collections of information. The collections of information in 21 CFR 202.1 have been approved under OMB control number 0910–0686. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Dated: June 23, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–13775 Filed 6–27–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–2370] Patient-Matched Guides to Orthopedic Implants; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Patient-Matched Guides to Orthopedic Implants.’’ This draft guidance document provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides to orthopedic implants. This draft guidance also provides recommendations that manufacturers should consider when developing their design process for these device types. SUMMARY: E:\FR\FM\28JNN1.SGM 28JNN1 41968 Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices This draft guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review. This draft guidance is not final nor is it for implementation at this time. DATES: Submit either electronic or written comments on the draft guidance by August 28, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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’’). ddrumheller on DSK120RN23PROD with NOTICES1 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– 2023–D–2370 for ‘‘Patient-Matched VerDate Sep<11>2014 18:48 Jun 27, 2023 Jkt 259001 Guides to Orthopedic Implants.’’ 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, 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-201509-18/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, 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 draft guidance document entitled ‘‘Patient-Matched Guides to Orthopedic Implants’’ to the Office of Policy, Center for Devices and PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Michel Janda, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4428, Silver Spring, MD 20993–0002, 301–796–6395. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Patient-Matched Guides to Orthopedic Implants.’’ FDA has developed this guidance document for members of industry who submit and FDA staff who review premarket submissions for patient-matched guides for orthopedic implants. Patientmatched guides are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. This draft guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review. Additionally, this draft guidance provides recommended best practices regarding certain elements of the design process. This draft guidance was part of the 2015 initiative to incorporate stakeholder feedback during guidance development (80 FR 1424, January 9, 2015) available at https:// www.federalregister.gov/documents/ 2015/01/09/2015-00115/medical-deviceuser-fee-and-modernization-act-noticeto-public-of-website-location-of-fiscalyear. Specific questions were posed to solicit input into the context of the guidance and comments were collected through Docket No. FDA–2012–N–1021. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Patient-Matched Guides to Orthopedic Implants.’’ 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. E:\FR\FM\28JNN1.SGM 28JNN1 41969 Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices II. Electronic Access Persons interested in obtaining a copy of the draft 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 https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https:// 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: 21 CFR Part Topic 807, subpart E ......................................... 820 ........................................................... 812 ........................................................... 814, subparts A through E ...................... 800, 801, and 809 ................................... Premarket notification .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation Investigational Device Exemption ............................................................................ Premarket approval ................................................................................................. Medical Device Labeling Regulations ..................................................................... Dated: June 22, 2023. Lauren K. Roth, Associate Commissioner for Policy. Electronic comments must be submitted on or before August 28, 2023. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 28, 2023. 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. ADDRESSES: You may submit comments on any guidance at any time as follows. [FR Doc. 2023–13730 Filed 6–27–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–0939] Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ This draft guidance describes FDA’s interpretation of, and policies concerning, the statutory prohibition on wholesaling for certain compounded drugs. This draft guidance also describes examples of how FDA intends to apply the statutory wholesaling provision. DATES: Submit either electronic or written comments on the draft guidance on or before August 28, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Please note that late, untimely filed comments will not be considered. SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES1 www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Patient-Matched Guides to Orthopedic Implants’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI01400006 and complete title to identify the guidance you are requesting. VerDate Sep<11>2014 18:48 Jun 27, 2023 Jkt 259001 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 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 OMB Control No. 0910–0120 0910–0073 0910–0078 0910–0231 0910–0485 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– 2023–D–0939 for ‘‘Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ 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, 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 E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41967-41969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13730]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2370]


Patient-Matched Guides to Orthopedic Implants; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Patient-Matched 
Guides to Orthopedic Implants.'' This draft guidance document provides 
recommendations regarding information that should be included in 
regulatory submissions for patient-matched guides to orthopedic 
implants. This draft guidance also provides recommendations that 
manufacturers should consider when developing their design process for 
these device types.

[[Page 41968]]

This draft guidance is intended to promote clarity and transparency as 
to expectations regarding submission recommendations for orthopedic 
patient-matched guides. Following such recommendations may increase 
efficiency and consistency in review. This draft guidance is not final 
nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by August 28, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2023-D-2370 for ``Patient-Matched Guides to Orthopedic Implants.'' 
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, 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.
    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.
    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 draft guidance document entitled 
``Patient-Matched Guides to Orthopedic Implants'' 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: Michel Janda, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4428, Silver Spring, MD 20993-0002, 301-796-6395.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Patient-Matched Guides to Orthopedic 
Implants.'' FDA has developed this guidance document for members of 
industry who submit and FDA staff who review premarket submissions for 
patient-matched guides for orthopedic implants. Patient-matched guides 
are intended to assist in the execution of a pre-surgical plan 
concurred upon by the patient's healthcare professional to position an 
orthopedic implant in a way consistent with the implant's indicated 
use. This draft guidance is intended to promote clarity and 
transparency as to expectations regarding submission recommendations 
for orthopedic patient-matched guides. Following such recommendations 
may increase efficiency and consistency in review. Additionally, this 
draft guidance provides recommended best practices regarding certain 
elements of the design process.
    This draft guidance was part of the 2015 initiative to incorporate 
stakeholder feedback during guidance development (80 FR 1424, January 
9, 2015) available at https://www.federalregister.gov/documents/2015/01/09/2015-00115/medical-device-user-fee-and-modernization-act-notice-to-public-of-website-location-of-fiscal-year. Specific questions were 
posed to solicit input into the context of the guidance and comments 
were collected through Docket No. FDA-2012-N-1021.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Patient-
Matched Guides to Orthopedic Implants.'' 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.

[[Page 41969]]

II. Electronic Access

    Persons interested in obtaining a copy of the draft 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Patient-Matched Guides to Orthopedic 
Implants'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number GUI01400006 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:

------------------------------------------------------------------------
          21 CFR Part                   Topic           OMB Control No.
------------------------------------------------------------------------
807, subpart E................  Premarket                      0910-0120
                                 notification.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
812...........................  Investigational                0910-0078
                                 Device Exemption.
814, subparts A through E.....  Premarket approval...          0910-0231
800, 801, and 809.............  Medical Device                 0910-0485
                                 Labeling Regulations.
------------------------------------------------------------------------


    Dated: June 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13730 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P

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