Document ID: FDA-2020-D-1118-0006
Agency: fda
Document Type: Notice
Title: Non-Clinical and Clinical Investigation
of Devices Used for the Treatment of
Benign Prostatic Hyperplasia;
Guidance for Industry and Food and
Drug Administration Staff; Availability
Posted Date: 2021-12-27T05:00Z

[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73298-73300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27919]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Non-Clinical and Clinical Investigation of Devices Used for the 
Treatment of Benign Prostatic Hyperplasia; 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 ``Non-Clinical and 
Clinical Investigation of Devices Used for the Treatment of Benign 
Prostatic Hyperplasia (BPH).'' This guidance identifies the key 
features of non-clinical and clinical investigational plans used to 
support investigational device exemption applications, premarket 
approval applications, De Novo classification requests, and some 
premarket notification submissions for devices used in the treatment of 
BPH.

DATES: The announcement of the guidance is published in the Federal 
Register on December 27, 2021.

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:
     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

[[Page 73299]]

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 ``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, 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 guidance document entitled 
``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 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

    As men age, the prostate enlarges over time, obstructing the 
prostatic urethra and resulting in anatomic and functional changes in 
the bladder. The resulting condition, known as benign prostatic 
hyperplasia (BPH), can be associated with decreased peak urinary flow 
rate and increased post void residual urine. Men with BPH experience 
bothersome lower urinary tract symptoms that affect their quality of 
life by disrupting sleep patterns or interfering with daily activities.
    This guidance revises the guidance entitled ``Guidance for the 
Non[hyphen]Clinical and Clinical Investigation of Devices Used for the 
Treatment of Benign Prostatic Hyperplasia (BPH) \1\,'' issued on August 
17, 2010 (``2010 BPH guidance''). This guidance identifies the key 
features of non-clinical and clinical investigational plans used to 
support investigational device exemption applications, premarket 
approval applications, De Novo classification requests, and some 
premarket notification submissions for devices used in the treatment of 
BPH. Some recommendations in this document may not apply to a 
particular device, and additional recommendations may be appropriate 
for novel device types or technologies. FDA will consider alternative 
non-clinical and clinical testing when the proposed alternatives are 
supported by an adequate scientific rationale.
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    \1\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-non-clinical-and-clinical-investigation-devices-used-treatment-benign-prostatic-hyperplasia.
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    FDA issued a 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) \2\,'' which proposed 
to add new devices within scope and updates to the animal and clinical 
studies sections of the 2010 BPH guidance. A notice of availability of 
the draft guidance appeared in the Federal Register of July 14, 2020 
(85 FR 42406). FDA considered comments received and revised the 
guidance as appropriate in response to the comments, including the 
following technical changes: Suggested examination of surrounding 
anatomy during animal studies for embolic devices; clarification of 
sexual function; additional specificity around the primary safety 
endpoint; inclusion of secondary endpoints such as return to normal 
activities; measuring prostate volume according to current clinical 
guidelines; additional post-treatment evaluation; and consideration of 
the addition or increase in medications or other modalities as 
treatment failure. The remainder of the content of the 2010 BPH 
guidance remains largely unchanged.
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    \2\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-guidance-non-clinical-and-clinical-investigation-devices-used-treatment-benign.
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    This guidance is being issued consistent with FDA's good guidance

[[Page 73300]]

practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on non-clinical and clinical investigation of 
devices used for the treatment of 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.

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 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 and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Non-Clinical and Clinical 
Investigation of Devices Used for the Treatment of Benign Prostatic 
Hyperplasia (BPH)'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1724 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 and guidance have been 
approved by OMB as listed in the following table:

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 21 CFR part; guidance; or FDA                              OMB Control
              form                        Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
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    Dated: December 20, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27919 Filed 12-23-21; 8:45 am]
BILLING CODE 4164-01-P