81 FR 938 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 5 (January 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 5 (January 8, 2016)
| Page Range | 938-940 | |
| FR Document | 2016-00111 |
[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)] [Notices] [Pages 938-940] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00111] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting will be held on February 25, 2016, from 8 a.m. to 6 p.m. and February 26, 2016, from 8 a.m. to 1 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900. [[Page 939]] Contact Person: Patricio G. Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, [email protected], 301-796-6875, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for ``TOPAS Treatment for Fecal Incontinence,'' by ASTORA Women's Health, LLC. The ``TOPAS Treatment for Fecal Incontinence'' device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). The proposed Indication for Use (IFU) for the ``TOPAS Treatment for Fecal Incontinence'' device, as stated in the PMA, is as follows: The ``TOPAS Treatment for Fecal Incontinence'' is intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies. On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. The applicable product codes are those related to urogynecologic surgical mesh as follows:OTN and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;'' PAG and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;'' PAH and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision mini-sling;'' OTO and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;'' PAJ and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;'' OTP and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed'' and PAI and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed.'' Some examples of the means by which these devices perform these functions and their respective IFU/Intended Use (IU) statements are: Urogynecologic surgical mesh instrumentation is used: [cir] IFU/IU: To aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment of female stress urinary incontinence. Examples of such surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. The committee, during session II, will discuss and make recommendations regarding the classification of the product code ``LKX'' and the associated device classification name, ``Device, Thermal, Hemorrhoids.'' The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade). [cir] IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids. Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater, and a sensor which provides temperature control/feedback. [cir] IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating. Uses speculum-like plastic container containing liquid to cool hemorrhoidal veins. [cir] IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. The committee, during session III, will discuss and make recommendations regarding the classification of the product code ``LRL'' and the associated device classification name, ``Cushion, Hemorrhoid.'' The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions). [cir] IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only. Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort. [cir] IFU/IU: Intended for the home convalescent patient with perineal discomfort. Uses a cushion that contains two internal molded structures that conform to the patient's shape. Exerts ``slight'' pressure on hemorrhoid. IFU/IU not required at the time of clearance. The committee, during session IV, will discuss and make recommendations regarding the classification of the product code ``LKN'' and the associated device classification name, ``Separator, automated, blood cell and plasma, therapeutic.'' The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments [[Page 940]] became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Utilizes a continuous flow centrifuge (max speed 3000 revolutions per minute) to separate source blood from a subject into blood components. [cir] IFU/IU: May be used to perform therapeutic plasma exchange. [cir] IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children. Uses continuous flow access to a rotating centrifuge to separate blood components. [cir] IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient. [cir] IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm and then by scrolling down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 17, 2016. Oral presentations from the public will be scheduled on February 25, 2016, between approximately 1 p.m. and 2 p.m. and on February 26, 2016, between approximately 8:30 a.m. and 9:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 9, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 10, 2016. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at [email protected], 301-796- 5966, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 4, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-00111 Filed 1-7-16; 8:45 am] BILLING CODE 4164-01-P
![938 Federal Register / Vol. 81, No. 5 / Friday, January 8, 2016 / Notices
claimed confidential information eligibility determinations for donors of HCT/P establishments concerning donor
redacted/blacked out, will be available HCT/Ps, with recommendations testing for HBsAg and total anti-HBc, in
for public viewing and posted on http:// concerning the use of FDA-licensed the 2007 Donor Eligibility Guidance.
www.regulations.gov. Submit both NAT in donor testing for HBV DNA. This draft guidance is being issued
copies to the Division of Dockets FDA considers the use of FDA-licensed consistent with FDA’s good guidance
Management. If you do not wish your HBV NAT in testing HCT/Ps donors to practices regulation (21 CFR 10.115).
name and contact information to be be necessary to adequately and The draft guidance, when finalized, will
made publicly available, you can appropriately reduce the risk of represent the current thinking of FDA
provide this information on the cover transmission of HBV. The FDA-licensed on the ‘‘Use of Nucleic Acid Tests to
sheet and not in the body of your HBV NAT can detect evidence of the Reduce the Risk of Transmission of
comments and you must identify this viral infection at an earlier stage than Hepatitis B Virus from Donors of
information as ‘‘confidential.’’ Any the HBsAg and total anti-HBc tests. Human Cells, Tissues, and Cellular and
information marked as ‘‘confidential’’ Therefore, FDA recommends the use of Tissue-Based Products.’’ It does not
will not be disclosed except in FDA-licensed HBV NAT for testing establish any rights for any person and
accordance with 21 CFR 10.20 and other donors of HCT/Ps for evidence of is not binding on FDA or the public.
applicable disclosure law. For more infection with HBV. You can use an alternative approach if
information about FDA’s posting of HBV is a major global public health it satisfies the requirements of the
comments to public dockets, see 80 FR concern and has been transmitted by applicable statutes and regulations.
56469, September 18, 2015, or access blood transfusions and tissue
transplantation. Available literature has II. Electronic Access
the information at: http://www.fda.gov/
regulatoryinformation/dockets/ indicated possible transmissions of HBV Persons with access to the Internet
default.htm. by hematopoietic stem cells and blood may obtain the draft guidance at either
Docket: For access to the docket to with HBV NAT positive/hepatitis B http://www.fda.gov/BiologicsBlood
read background documents or the surface antigen (anti-HBs) positive/ Vaccines/GuidanceCompliance
electronic and written/paper comments HBsAg negative blood, irrespective of RegulatoryInformation/Guidances/
received, go to http:// anti-HBc test results. In blood donors, default.htm or http://
www.regulations.gov and insert the adding the HBV NAT testing for HBV www.regulations.gov.
docket number, found in brackets in the reduces the residual risk of transmission Dated: January 5, 2016.
heading of this document, into the of HBV infection beyond that which can
Leslie Kux,
‘‘Search’’ box and follow the prompts be achieved by screening donors using
Associate Commissioner for Policy.
and/or go to the Division of Dockets only HBsAg and total anti-HBc tests. In
addition, it can detect breakthrough [FR Doc. 2016–00149 Filed 1–7–16; 8:45 am]
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. infections in previously vaccinated BILLING CODE 4164–01–P
Submit written requests for single individuals who are exposed to the
copies of the draft guidance to the Office virus, and HBV mutants appear to be
more likely detected by HBV NAT than DEPARTMENT OF HEALTH AND
of Communication, Outreach and HUMAN SERVICES
Development, Center for Biologics by HBsAg assays.
In the United States, there are
Evaluation and Research (CBER), Food Food and Drug Administration
currently FDA-licensed HBV NAT
and Drug Administration, 10903 New
assays with an indication for screening [Docket No. FDA–2015–N–0001]
Hampshire Ave., Bldg. 71, Rm. 3128,
donor blood samples for Whole Blood
Silver Spring, MD 20993–0002. Send Gastroenterology and Urology Devices
and Blood components, other living
one self-addressed adhesive label to Panel of the Medical Devices Advisory
donors (individual organ donors when
assist the office in processing your Committee; Notice of Meeting
specimens are obtained while the
requests. The draft guidance may also be
donor’s heart is still beating), and blood AGENCY: Food and Drug Administration,
obtained by mail by calling CBER at 1–
specimens from cadaveric (non-heart- HHS.
800–835–4709 or 240–402–8010. See beating) donors. Some of these are
the SUPPLEMENTARY INFORMATION section ACTION: Notice.
multiplex assays that can
for electronic access to the draft simultaneously detect HIV, HCV, and
guidance document. This notice announces a forthcoming
HBV in a single blood specimen, thus meeting of a public advisory committee
FOR FURTHER INFORMATION CONTACT: improving the feasibility of routine NAT of the Food and Drug Administration
Jessica T. Walker, Center for Biologics testing for HBV. By analogy to the (FDA). The meeting will be open to the
Evaluation and Research, Food and experience in the blood donor setting, it public.
Drug Administration, 10903 New is reasonable to expect that the residual Name of Committee: Gastroenterology
Hampshire Ave., Bldg. 71, Rm. 7301, risk of transmission of HBV infection and Urology Devices Panel of the
Silver Spring, MD 20993–0002, 240– would be reduced by adding HBV NAT Medical Devices Advisory Committee.
402–7911. to the testing strategy for HCT/P donors. General Function of the Committee:
SUPPLEMENTARY INFORMATION: HBV NAT’s potential utility in further To provide advice and
reducing risk of HBV transmission by recommendations to the Agency on
I. Background transplantation is mainly restricted to FDA’s regulatory issues.
FDA is announcing the availability of the early HBsAg-negative phase of Date and Time: The meeting will be
mstockstill on DSK4VPTVN1PROD with NOTICES6
a draft document entitled ‘‘Use of infection. In summary, the available held on February 25, 2016, from 8 a.m.
Nucleic Acid Tests to Reduce the Risk scientific data and the availability of to 6 p.m. and February 26, 2016, from
of Transmission of Hepatitis B Virus FDA-licensed assays support a 8 a.m. to 1 p.m.
from Donors of Human Cells, Tissues, recommendation that all HCT/Ps donors Location: Hilton Washington DC
and Cellular and Tissue-Based Products; should be tested using an FDA-licensed North/Gaithersburg, Salons A, B, and C,
Draft Guidance for Industry.’’ The draft HBV NAT. The draft guidance, when 620 Perry Pkwy., Gaithersburg, MD
guidance document provides finalized, is intended to supplement 20877. The hotel’s telephone number is
establishments that make donor previous FDA recommendations to 301–977–8900.
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![940 Federal Register / Vol. 81, No. 5 / Friday, January 8, 2016 / Notices
became effective. Some examples of the public hearing session. The contact extension to allow interested persons
means by which these devices perform person will notify interested persons additional time to submit comments.
these functions and their respective regarding their request to speak by DATES: FDA is extending the comment
IFU/IU statements are: February 10, 2016. period for the draft guidance by an
• Utilizes a continuous flow Persons attending FDA’s advisory additional 30 days. Although you can
centrifuge (max speed 3000 revolutions committee meetings are advised that the comment on any guidance at any time
per minute) to separate source blood Agency is not responsible for providing (see 21 CFR 10.115(g)(5)), to permit the
from a subject into blood components. access to electrical outlets. Agency to consider your comments
Æ IFU/IU: May be used to perform FDA welcomes the attendance of the before issuing the final version of the
therapeutic plasma exchange. public at its advisory committee guidance, submit either electronic or
Æ IFU/IU: May be used to perform meetings and will make every effort to written comments on the draft guidance
Red Blood Cell Exchange procedures for accommodate persons with disabilities. by February 22, 2016.
the transfusion management of Sickle If you require accommodations due to a
Cell Disease in adults and children. ADDRESSES: You may submit comments
disability, please contact AnnMarie
• Uses continuous flow access to a Williams at
as follows:
rotating centrifuge to separate blood annmarie.williams@fda.hhs.gov, 301– Electronic Submissions
components. 796–5966, at least 7 days in advance of
Æ IFU/IU: May be used to harvest Submit electronic comments in the
the meeting. following way:
cellular components from the blood of
FDA is committed to the orderly • Federal eRulemaking Portal: http://
certain patients where the attending
conduct of its advisory committee www.regulations.gov. Follow the
physician feels the removal of such
component may benefit the patient. meetings. Please visit our Web site at instructions for submitting comments.
Æ IFU/IU: May be used to remove http://www.fda.gov/Advisory Comments submitted electronically,
plasma components and/or fluid Committees/AboutAdvisoryCommittees/ including attachments, to http://
selected by the attending physicians. ucm111462.htm for procedures on www.regulations.gov will be posted to
FDA intends to make background public conduct during advisory the docket unchanged. Because your
material available to the public no later committee meetings. comment will be made public, you are
than 2 business days before the meeting. Notice of this meeting is given under solely responsible for ensuring that your
If FDA is unable to post the background the Federal Advisory Committee Act (5 comment does not include any
material on its Web site prior to the U.S.C. app. 2). confidential information that you or a
meeting, the background material will Dated: January 4, 2016. third party may not wish to be posted,
be made publicly available at the Jill Hartzler Warner, such as medical information, your or
location of the advisory committee Associate Commissioner for Special Medical anyone else’s Social Security number, or
meeting, and the background material Programs. confidential business information, such
will be posted on FDA’s Web site after [FR Doc. 2016–00111 Filed 1–7–16; 8:45 am] as a manufacturing process. Please note
the meeting. Background material is BILLING CODE 4164–01–P
that if you include your name, contact
available at http://www.fda.gov/ information, or other information that
AdvisoryCommittees/Calendar/ identifies you in the body of your
default.htm and then by scrolling down DEPARTMENT OF HEALTH AND comments, that information will be
to the appropriate advisory committee HUMAN SERVICES posted on http://www.regulations.gov.
meeting link. • If you want to submit a comment
Procedure: Interested persons may Food and Drug Administration with confidential information that you
present data, information, or views, do not wish to be made available to the
orally or in writing, on issues pending [Docket No. FDA–2015–D–4021]
public, submit the comment as a
before the committee. Written written/paper submission and in the
Over-the-Counter Sunscreens: Safety
submissions may be made to the contact manner detailed (see ‘‘Written/Paper
and Effectiveness Data; Draft
person on or before February 17, 2016. Submissions’’ and ‘‘Instructions’’).
Guidance for Industry; Extension of
Oral presentations from the public will
Comment Period Written/Paper Submissions
be scheduled on February 25, 2016,
between approximately 1 p.m. and 2 AGENCY: Food and Drug Administration, Submit written/paper submissions as
p.m. and on February 26, 2016, between HHS. follows:
approximately 8:30 a.m. and 9:30 a.m. Notice; extension of the
ACTION: • Mail/Hand delivery/Courier (for
Those individuals interested in making comment period. written/paper submissions): Division of
formal oral presentations should notify Dockets Management (HFA–305), Food
the contact person and submit a brief SUMMARY: The Food and Drug and Drug Administration, 5630 Fishers
statement of the general nature of the Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
evidence or arguments they wish to extending the comment period provided • For written/paper comments
present, the names and addresses of in the notice entitled ‘‘Over-the-Counter submitted to the Division of Dockets
proposed participants, and an Sunscreens: Safety and Effectiveness Management, FDA will post your
indication of the approximate time Data; Draft Guidance for Industry; comment, as well as any attachments,
requested to make their presentation on Availability’’ that appeared in the except for information submitted,
mstockstill on DSK4VPTVN1PROD with NOTICES6
or before February 9, 2016. Time Federal Register on November 23, 2015 marked and identified, as confidential,
allotted for each presentation may be (80 FR 72975). That notice announced if submitted as detailed in
limited. If the number of registrants the availability of a draft guidance for ‘‘Instructions.’’
requesting to speak is greater than can industry and requested comments to Instructions: All submissions received
be reasonably accommodated during the that draft guidance by January 22, 2016. must include the Docket No. FDA–
scheduled open public hearing session, FDA is extending the draft guidance’s 2015–D–4021 for ‘‘Over-the-Counter
FDA may conduct a lottery to determine comment period by 30 days (to February Sunscreens: Safety and Effectiveness
the speakers for the scheduled open 22, 2016) in response to a request for an Data; Draft Guidance for Industry.’’
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Document Created: 2016-01-16 01:15:25
Document Modified: 2016-01-16 01:15:25
| 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. | |
| FR Citation | 81 FR 938 |
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