[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42858-42860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15263]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2223]


Clinical Investigations for Prostate Tissue Ablation Devices; 
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 the Agency) is 
announcing the availability of a final guidance entitled ``Clinical 
Investigations for Prostate Tissue Ablation Devices.'' This guidance 
provides recommendations for clinical investigations for high intensity 
ultrasound systems for prostate tissue ablation and new types of 
prostatic tissue ablation devices.

DATES: The announcement of the guidance is published in the Federal 
Register on July 15, 2020.

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 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-2019-D-2223 for ``Clinical Investigations for Prostate Tissue 
Ablation Devices.'' 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

[[Page 42859]]

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 
``Clinical Investigations for Prostate Tissue Ablation Devices'' 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: John Baxley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2626, Silver Spring, MD 20993-0002, 301-796-6549.

SUPPLEMENTARY INFORMATION: 

I. Background

    This guidance provides draft recommendations for: (1) Complying 
with the clinical testing special control under 21 CFR 876.4340(b)(8) 
for premarket notifications (510(k)s) for high intensity ultrasound 
systems for prostate tissue ablation and (2) collecting clinical data 
to support marketing submissions for new types of prostatic tissue 
ablation devices. High intensity ultrasound systems for prostate tissue 
ablation transmit high intensity therapeutic ultrasound energy into the 
prostate to thermally ablate a defined, targeted volume of tissue. 
Other prostate ablation devices achieve the same clinical effect of 
ablating targeted tissue volumes using different sources of energy.
    The scope of this guidance is limited to the clinical 
investigations of prostate tissue ablation systems to support marketing 
authorization for a general indication for ablation of prostatic 
tissue. This guidance does not address the clinical investigations of 
devices that are intended to treat specific prostatic diseases (e.g., 
prostate cancer or benign prostatic hyperplasia). Additionally, this 
document does not address recommendations for non-clinical testing of 
prostate tissue ablation systems.
    A notice of availability for the draft guidance appeared in the 
Federal Register of June 26, 2019 (84 FR 30125). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including minor edits to clarify and better explain 
FDA's recommendations for the clinical study design. 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 
clinical investigations for prostate tissue ablation devices. 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. Persons unable to download an 
electronic copy of ``Clinical Investigations for Prostate Tissue 
Ablation Devices'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 16011 to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    This 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:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback and         Q-submissions.......       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
50, 56............................  Protection of Human        0910-0755
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
56................................  Institutional Review       0910-0130
                                     Boards.
------------------------------------------------------------------------



[[Page 42860]]

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15263 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


