Notice2021-27919
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
Primary source
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Published
December 27, 2021
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 "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.
Full Text
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<title>Federal Register, Volume 86 Issue 245 (Monday, December 27, 2021)</title>
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[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73298-73300]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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
[[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 <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-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 <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 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
``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: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-non-clinical-and-clinical-investigation-devices-used-treatment-benign-prostatic-hyperplasia">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-non-clinical-and-clinical-investigation-devices-used-treatment-benign-prostatic-hyperplasia</a>.
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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: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-guidance-non-clinical-and-clinical-investigation-devices-used-treatment-benign">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-guidance-non-clinical-and-clinical-investigation-devices-used-treatment-benign</a>.
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This guidance is being issued consistent with FDA's good guidance
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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 <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 at <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 ``Non-Clinical and Clinical
Investigation of Devices Used for the Treatment of Benign Prostatic
Hyperplasia (BPH)'' may send an email request to <a href="/cdn-cgi/l/email-protection#ffbcbbadb7d2b88a969b9e919c9abf999b9ed197978cd1989089"><span class="__cf_email__" data-cfemail="99daddcbd1b4deecf0fdf8f7fafcd9fffdf8b7f1f1eab7fef6ef">[email protected]</span></a> 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
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