[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70193-70194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27857]



[[Page 70193]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1804]


Immediately in Effect Guidance Document: Product Labeling for 
Laparoscopic Power Morcellators; Guidance for Industry and Food and 
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance for industry and FDA staff entitled 
``Immediately in Effect Guidance Document: Product Labeling for 
Laparoscopic Power Morcellators.'' FDA is issuing this guidance to 
recommend the addition of specific safety statements to the product 
labeling for laparoscopic power morcellators (LPMs). The Agency is 
making these recommendations in light of scientific information that 
suggests that the use of these devices contributes to the dissemination 
and upstaging of an occult uterine malignancy in women undergoing 
laparoscopic gynecologic surgery for presumed fibroids. FDA believes 
this effort will promote the safe and effective use of LPMs when used 
for gynecologic surgeries.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: 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 
``Immediately in Effect Guidance Document: Product Labeling for 
Laparoscopic Power Morcellators'' 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-addressed 
adhesive label to assist that office in processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Immediately in Effect Guidance Document: Product 
Labeling for Laparoscopic Power Morcellators.'' This guidance is being 
implemented without prior public comment because the Agency has 
determined that prior public participation is not feasible or 
appropriate (21 CFR 10.115(g)(2)). FDA believes that immediate 
implementation of the guidance is needed to assist in addressing a 
significant public health issue. Although this guidance document is 
immediately in effect, FDA will consider all comments received and 
revise the guidance document when appropriate.
    As the number of laparoscopic and minimally invasive procedures has 
increased through the introduction of new surgical technologies and 
techniques, additional safety information has become available 
regarding the use of LPMs. Recent discussions within the patient and 
clinical communities, as well as the peer-reviewed medical literature, 
have raised awareness of the risk of spreading unsuspected cancerous 
tissue beyond the uterus when LPMs are used during gynecologic 
surgeries intended to treat benign fibroids. Numerous case reports and 
case series have been published that describe the iatrogenic 
dissemination, implantation, and subsequent growth of unsuspected 
neoplastic tissue within the peritoneal cavity following laparoscopic 
morcellation of uterine tissue believed to contain fibroids based on 
preoperative diagnosis.
    FDA's recent analysis of available information suggested that the 
risk of an occult uterine sarcoma in a woman undergoing surgical 
intervention for presumed fibroids is substantially higher than had 
previously been assumed or reported. FDA's analysis also suggested that 
patient outcomes, including survival, may be significantly adversely 
impacted from this upstaging of disease. Patient selection and choice 
of surgical technique can reduce the risk of spreading cancer. 
Specifically, the prevalence of unsuspected cancer in women undergoing 
hysterectomy for fibroids increases with age such that the benefit/risk 
profile of using LPMs is worse in peri- and post-menopausal women 
compared to pre-menopausal women. The surgical technique of en bloc 
tissue removal eliminates the need to perform morcellation, thereby 
reducing the risk of iatrogenic dissemination and upstaging an occult 
sarcoma. Importantly, no screening procedure that can reliably detect 
sarcoma preoperatively has been identified.
    FDA considers this new scientific information to represent a 
significant change to the benefit/risk profile for these devices, 
prompting the issuance of a Safety Communication on April 17, 2014 
(Ref. 1), and convening of the FDA's Obstetrics and Gynecology Devices 
Panel of the Medical Devices Advisory Committee on July 10-11, 2014 
(Ref. 2), to further discuss the use and labeling of LPMs during 
gynecologic surgeries. FDA is issuing this document after considering 
the input of the Panel and other stakeholders, including comments made 
during the Open Public Hearing portion of the Panel meeting.
    As a result of the new information and discussions during the 
public Advisory Committee meeting, FDA recommends that manufacturers of 
LPMs with a general indication or a specific gynecologic indication 
prominently include two specific Contraindications and a specific Boxed 
Warning in their product labeling. FDA believes this may be information 
that manufacturers should disclose to users under sections 201(n), 
502(a), and 502(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(n), 352(a) and 352(f)(2)). The issuance of this guidance 
represents another step in addressing this serious public health issue. 
In the future, additional safety communications, guidance, or 
rulemaking may be undertaken to further support the safe and effective 
use of LPMs.

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 
Agency's current thinking on product labeling for LPMs. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by

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downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Immediately in Effect 
Guidance Document: Product Labeling for Laparoscopic Power 
Morcellators'' may send an email request to [email protected] 
to receive an electronic copy of the document. Please use the document 
number 1400052 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.
    In addition, FDA concludes that the labeling statements in the 
guidance do not constitute a ``collection of information'' under the 
Paperwork Reduction Act. Rather, the labeling statements are ``public 
disclosure of information originally supplied by the Federal government 
to the recipient for the purpose of disclosure to the public.'' (5 CFR 
1320.3(c)(2)).

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses in this reference section, but FDA 
is not responsible for any subsequent changes to the Web sites after 
this document publishes in the Federal Register.)

1. FDA Center for Devices and Radiological Health, Safety 
Communications Page, ``Laparoscopic Uterine Power Morcellation in 
Hysterectomy and Myomectomy,'' (http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm).
2. Public meeting in 2014, Obstetrics and Gynecology Devices Panel 
of the Medical Devices Advisory Committee, Federal Register notice, 
available at http://www.gpo.gov/fdsys/pkg/FR-2014-06-09/pdf/2014-13290.pdf.

    Dated: November 19, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27857 Filed 11-24-14; 8:45 am]
BILLING CODE 4164-01-P