[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42406-42407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1118]


Select Updates for Guidance for the Non-Clinical and Clinical 
Investigation of Devices Used for the Treatment of Benign Prostatic 
Hyperplasia; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Select Updates for 
Guidance for the Non-Clinical and Clinical Investigation of Devices 
Used for the Treatment of Benign Prostatic Hyperplasia (BPH).'' FDA has 
developed this draft guidance to propose select updates to certain 
sections of the existing FDA guidance document ``Guidance for the 
Non[hyphen]Clinical and Clinical Investigation of Devices Used for the 
Treatment of Benign Prostatic Hyperplasia (BPH).'' This draft guidance 
is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by September 14, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2020-D-1118 for ``Select Updates for Guidance for the Non-Clinical 
and Clinical Investigation of Devices Used for the Treatment of Benign 
Prostatic Hyperplasia (BPH).'' 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.
    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 
``Select Updates for Guidance for the Non-Clinical and Clinical 
Investigation of Devices Used for the Treatment of Benign Prostatic 
Hyperplasia (BPH)'' to the Office of Policy, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug

[[Page 42407]]

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: Charles Viviano, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993-0002, 240-
402-2975.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this draft guidance to propose select updates to 
the FDA guidance document ``Guidance for the Non[hyphen]Clinical and 
Clinical Investigation of Devices Used for the Treatment of Benign 
Prostatic Hyperplasia (BPH).'' The existing guidance on devices used 
for the treatment of BPH remains in effect, in its current form, until 
this draft guidance is finalized. FDA intends to incorporate this draft 
guidance into one final guidance document after obtaining and 
considering public comment on these select updates. The sections of the 
existing BPH guidance that are not affected by this select update will 
not be substantively changed and will remain in effect.

II. Significance of Guidance

    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 ``Select 
Updates for Guidance for the Non-Clinical and Clinical Investigation of 
Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).'' 
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.

III. 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Select Updates for 
Guidance for the Non-Clinical and Clinical Investigation of Devices 
Used for the Treatment of Benign Prostatic Hyperplasia (BPH)'' may send 
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1724 and the full 
title to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved 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 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
     21 CFR part or guidance              Topic          OMB control No.
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58...............................  Good Laboratory             0910-0119
                                    Practice (GLP)
                                    Regulations for
                                    Nonclinical
                                    Laboratory Studies.
800, 801, and 809................  Medical Device              0910-0485
                                    Labeling
                                    Regulations.
807, subpart E...................  Premarket                   0910-0120
                                    Notification.
812..............................  Investigational             0910-0078
                                    Device Exemption.
814, subparts A through E........  Premarket Approval          0910-0231
                                    Applications.
``De Novo Classification Process   De Novo                     0910-0844
 (Evaluation of Automatic Class     Classification
 III Designation)''.                Process.
``Requests for Feedback on         Q-submissions......         0910-0756
 Medical Device Submissions: The
 Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
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    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15089 Filed 7-13-20; 8:45 am]
BILLING CODE 4164-01-P


