82 FR 50138 - Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 208 (October 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 208 (October 30, 2017)
| Page Range | 50138-50139 | |
| FR Document | 2017-23520 |
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)] [Notices] [Pages 50138-50139] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23520] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-3275] Product Labeling for Certain Ultrasonic Surgical Aspirator 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 Agency) is announcing the availability of the guidance entitled ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroids. DATES: The announcement of the guidance is published in the Federal Register on October 30, 2017. 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 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-2016-D-3275 for ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff.'' 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 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 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.thefederalregister.org/fdsys/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 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 guidance document entitled ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices'' to the Office of the Center Director, 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- [[Page 50139]] addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Trisha Eustaquio, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 301- 796-5214. SUPPLEMENTARY INFORMATION: I. Background FDA is issuing this guidance to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. This guidance applies to ultrasonic surgical aspirator devices with indications for use in laparoscopic surgery, open surgery, or gynecologic surgery, as such surgeries can include gynecologic procedures. Ultrasonic surgical aspirator devices are surgical tools intended to fragment, emulsify, and aspirate hard and soft tissue. However, the mechanism of action of ultrasonic surgical aspirator devices creates the potential for tissue dissemination. In light of this risk, FDA is providing a specific labeling recommendation in this guidance regarding use of these devices in the removal of uterine fibroids. FDA is aware that ultrasonic surgical aspirator devices are sometimes used to treat advanced malignancy through cytoreduction (also known as debulking). When used in advanced cancers, the risk of adverse clinical effects from tissue dissemination may be small compared to the device's potential benefits. In certain clinical circumstances, however, the unintended dissemination of cancerous cells may have a significant adverse effect that outweighs any demonstrated benefits. Specifically, use of an ultrasonic surgical aspirator device during treatment for symptomatic uterine fibroids on a woman with an occult uterine sarcoma could result in dissemination of this cancer. Therefore, FDA recommends that manufacturers of ultrasonic surgical aspirator devices with indications for use in laparoscopic surgery, open surgery, or gynecologic surgery prominently include a specific contraindication in their product labeling that the device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids. In the Federal Register on November 10, 2016 (81 FR 79028), FDA announced the availability of the draft guidance and interested parties were invited to comment by January 9, 2017. FDA has considered all of the public comments received prior to finalizing this guidance. II. Significance of Guidance 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 ``Product Labeling for Certain Ultrasonic Surgical Aspirator 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. This guidance is not subject to Executive Order 12866. III. 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500072 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. 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. 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120 and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485. Dated: October 25, 2017. Lauren Silvis, Chief of Staff. [FR Doc. 2017-23520 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
![50138 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Total
Number of Average
Number of Total annual operating and
Activity responses per burden per Total hours
respondents responses maintenance
respondent response costs 2
Total ......................................... ........................ ........................ ........................ ........................ 7,434 $6,313
1 There are no capital costs associated with this collection of information.
2 No change from approved information collection. This information is retained for the convenience of the reader.
Dated: October 24, 2017. comment does not include any ‘‘THIS DOCUMENT CONTAINS
Anna K. Abram, confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
Deputy Commissioner for Policy, Planning, third party may not wish to be posted, Agency will review this copy, including
Legislation, and Analysis. such as medical information, your or the claimed confidential information, in
[FR Doc. 2017–23500 Filed 10–27–17; 8:45 am] anyone else’s Social Security number, or its consideration of comments. The
BILLING CODE 4164–01–P confidential business information, such second copy, which will have the
as a manufacturing process. Please note claimed confidential information
that if you include your name, contact redacted/blacked out, will be available
DEPARTMENT OF HEALTH AND information, or other information that for public viewing and posted on
HUMAN SERVICES identifies you in the body of your https://www.regulations.gov. Submit
comments, that information will be both copies to Dockets Management
Food and Drug Administration posted on https://www.regulations.gov. Staff. If you do not wish your name and
• If you want to submit a comment contact information to be made publicly
[Docket No. FDA–2016–D–3275] with confidential information that you available, you can provide this
Product Labeling for Certain Ultrasonic do not wish to be made available to the information on the cover sheet and not
Surgical Aspirator Devices; Guidance public, submit the comment as a in the body of your comments and you
for Industry and Food and Drug written/paper submission and in the must identify this information as
Administration Staff; Availability manner detailed (see ‘‘Written/Paper ‘‘confidential.’’ Any information marked
Submissions’’ and ‘‘Instructions’’). as ‘‘confidential’’ will not be disclosed
AGENCY: Food and Drug Administration, Written/Paper Submissions except in accordance with 21 CFR 10.20
HHS. and other applicable disclosure law. For
Submit written/paper submissions as more information about FDA’s posting
ACTION: Notice of availability.
follows:
of comments to public dockets, see 80
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
FR 56469, September 18, 2015, or access
Administration (FDA or Agency) is written/paper submissions): Dockets
Management Staff (HFA–305), Food and the information at: https://www.gpo.gov/
announcing the availability of the fdsys/pkg/FR-2015-09-18/pdf/2015-
guidance entitled ‘‘Product Labeling for Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. 23389.pdf.
Certain Ultrasonic Surgical Aspirator Docket: For access to the docket to
Devices.’’ FDA is providing a specific • For written/paper comments
submitted to Dockets Management Staff, read background documents or the
labeling recommendation in this electronic and written/paper comments
guidance to promote the safe and FDA will post your comment, as well as
any attachments, except for information received, go to https://
effective use of ultrasonic surgical www.regulations.gov and insert the
aspirator devices. The labeling submitted, marked and identified, as
confidential, if submitted as detailed in docket number, found in brackets in the
recommendation is being made in light heading of this document, into the
‘‘Instructions.’’
of the risk of tissue dissemination and ‘‘Search’’ box and follow the prompts
Instructions: All submissions received
relates to use of these devices in the and/or go to Dockets Management Staff,
must include the Docket No. FDA–
removal of uterine fibroids. 2016–D–3275 for ‘‘Product Labeling for 5630 Fishers Lane, Rm. 1061, Rockville,
DATES: The announcement of the Certain Ultrasonic Surgical Aspirator MD 20852.
guidance is published in the Federal Devices; Guidance for Industry and You may submit comments on any
Register on October 30, 2017. Food and Drug Administration Staff.’’ guidance at any time (see 21 CFR
ADDRESSES: You may submit either Received comments will be placed in 10.115(g)(5)).
electronic or written comments on the docket and, except for those An electronic copy of the guidance
Agency guidances at any time as submitted as ‘‘Confidential document is available for download
follows: Submissions,’’ publicly viewable at from the internet. See the
https://www.regulations.gov or at SUPPLEMENTARY INFORMATION section for
Electronic Submissions information on electronic access to the
Dockets Management Staff between 9
Submit electronic comments in the a.m. and 4 p.m., Monday through guidance. Submit written requests for a
following way: Friday. single hard copy of the guidance
• Federal eRulemaking Portal: • Confidential Submissions—To document entitled ‘‘Product Labeling for
https://www.regulations.gov. Follow the submit a comment with confidential Certain Ultrasonic Surgical Aspirator
sradovich on DSK3GMQ082PROD with NOTICES
instructions for submitting comments. information that you do not wish to be Devices’’ to the Office of the Center
Comments submitted electronically, made publicly available, submit your Director, Guidance and Policy
including attachments, to https:// comments only as a written/paper Development, Center for Devices and
www.regulations.gov will be posted to submission. You should submit two Radiological Health, Food and Drug
the docket unchanged. Because your copies total. One copy will include the Administration, 10903 New Hampshire
comment will be made public, you are information you claim to be confidential Ave., Bldg. 66, Rm. 5431, Silver Spring,
solely responsible for ensuring that your with a heading or cover note that states MD 20993–0002. Send one self-
VerDate Sep<11>2014 17:59 Oct 27, 2017 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/82_FR_50346/page/1.svg)
![Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50139
addressed adhesive label to assist that received prior to finalizing this DEPARTMENT OF HEALTH AND
office in processing your request. guidance. HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT: II. Significance of Guidance Food and Drug Administration
Trisha Eustaquio, Center for Devices
and Radiological Health, Food and Drug This guidance is being issued [Docket No. FDA–2017–N–5925]
Administration, 10903 New Hampshire consistent with FDA’s good guidance
Ave., Bldg. 66, Rm. 1529, Silver Spring, practices regulation (21 CFR 10.115). Standard Development Organizations
MD 20993–0002, 301–796–5214. The guidance represents the current Whose Susceptibility Test Interpretive
SUPPLEMENTARY INFORMATION: thinking of FDA on ‘‘Product Labeling Criteria Standards May Be Recognized
for Certain Ultrasonic Surgical Aspirator by the Food and Drug Administration;
I. Background Devices.’’ It does not establish any rights Request for Information
FDA is issuing this guidance to for any person and is not binding on AGENCY: Food and Drug Administration,
recommend the addition of a specific FDA or the public. You can use an HHS.
safety statement to the product labeling alternative approach if it satisfies the
ACTION: Request for information.
of certain ultrasonic surgical aspirator requirements of the applicable statutes
devices. This guidance applies to and regulations. This guidance is not SUMMARY: The Food and Drug
ultrasonic surgical aspirator devices subject to Executive Order 12866. Administration (FDA, the Agency, or
with indications for use in laparoscopic we) is requesting information to assist in
surgery, open surgery, or gynecologic III. Electronic Access
identifying standard development
surgery, as such surgeries can include Persons interested in obtaining a copy organizations (SDOs) that meet the
gynecologic procedures. Ultrasonic of the guidance may do so by requirements in the Federal Food, Drug,
surgical aspirator devices are surgical downloading an electronic copy from and Cosmetic Act (FD&C Act), of the
tools intended to fragment, emulsify, the internet. A search capability for all 21st Century Cures Act (Cures Act),
and aspirate hard and soft tissue. Center for Devices and Radiological which was signed into law on December
However, the mechanism of action of 13, 2016.
Health guidance documents is available
ultrasonic surgical aspirator devices DATES: Submit either electronic or
at https://www.fda.gov/MedicalDevices/
creates the potential for tissue written comments on the notice by
dissemination. In light of this risk, FDA DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. November 29, 2017.
is providing a specific labeling
Guidance documents are also available ADDRESSES: You may submit comments
recommendation in this guidance
at https://www.regulations.gov. Persons and information as follows. Please note
regarding use of these devices in the
unable to download an electronic copy that late, untimely filed comments will
removal of uterine fibroids.
of ‘‘Product Labeling for Certain not be considered. Electronic comments
FDA is aware that ultrasonic surgical must be submitted on or before
aspirator devices are sometimes used to Ultrasonic Surgical Aspirator Devices;
Guidance for Industry and Food and November 29, 2017. The https://
treat advanced malignancy through www.regulations.gov electronic filing
cytoreduction (also known as Drug Administration Staff’’ may send an
system will accept comments until
debulking). When used in advanced email request to CDRH-Guidance@
midnight Eastern Time at the end of
cancers, the risk of adverse clinical fda.hhs.gov to receive an electronic
November 29, 2017. Comments received
effects from tissue dissemination may be copy of the document. Please use the
by mail/hand delivery/courier (for
small compared to the device’s potential document number 1500072 to identify written/paper submissions) will be
benefits. In certain clinical the guidance you are requesting. considered timely if they are
circumstances, however, the unintended postmarked or the delivery service
IV. Paperwork Reduction Act of 1995
dissemination of cancerous cells may acceptance receipt is on or before that
have a significant adverse effect that This guidance refers to previously date.
outweighs any demonstrated benefits. approved collections of information
Specifically, use of an ultrasonic Electronic Submissions
found in FDA regulations. These
surgical aspirator device during collections of information are subject to Submit electronic comments in the
treatment for symptomatic uterine review by the Office of Management and following way:
fibroids on a woman with an occult Budget (OMB) under the Paperwork • Federal eRulemaking Portal:
uterine sarcoma could result in https://www.regulations.gov. Follow the
Reduction Act of 1995 (44 U.S.C. 3501–
dissemination of this cancer. Therefore, instructions for submitting comments.
3520). The collections of information in
FDA recommends that manufacturers of Comments submitted electronically,
21 CFR part 807, subpart E have been
ultrasonic surgical aspirator devices including attachments, to https://
with indications for use in laparoscopic approved under OMB control number
0910–0120 and the collections of www.regulations.gov will be posted to
surgery, open surgery, or gynecologic the docket unchanged. Because your
surgery prominently include a specific information in 21 CFR part 801 have
comment will be made public, you are
contraindication in their product been approved under OMB control
solely responsible for ensuring that your
labeling that the device is not indicated number 0910–0485. comment does not include any
for and should not be used for the Dated: October 25, 2017. confidential information that you or a
fragmentation, emulsification, and third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES
Lauren Silvis,
aspiration of uterine fibroids. such as medical information, your or
Chief of Staff.
In the Federal Register on November [FR Doc. 2017–23520 Filed 10–27–17; 8:45 am]
anyone else’s Social Security number, or
10, 2016 (81 FR 79028), FDA announced confidential business information, such
BILLING CODE 4164–01–P
the availability of the draft guidance and as a manufacturing process. Please note
interested parties were invited to that if you include your name, contact
comment by January 9, 2017. FDA has information, or other information that
considered all of the public comments identifies you in the body of your
VerDate Sep<11>2014 17:59 Oct 27, 2017 Jkt 244001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/82_FR_50346/page/2.svg)
Document Created: 2017-10-28 00:29:09
Document Modified: 2017-10-28 00:29:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on October 30, 2017. | |
| Contact | Trisha Eustaquio, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 301- 796-5214. | |
| FR Citation | 82 FR 50138 |
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