[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
[[Page 70194]]
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