Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 66942-66944 [2013-26722]

Download as PDF 66942 Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices tkelley on DSK3SPTVN1PROD with NOTICES 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: For devices regulated by CDRH: Gregory Campbell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2110, Silver Spring, MD 20993–0002, 301–796–5750. For devices regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. I. Background The guidance document is intended to provide guidance to those involved in designing clinical studies that support premarket submissions for medical devices and FDA staff who review those submissions. Although the Agency has articulated policies related to design of studies intended to support specific device types, and a general policy of tailoring the evidentiary burden to the regulatory requirement, the Agency has not attempted to describe the different clinical study designs that may be appropriate to support a device premarket submission, or to define how a sponsor should decide which pivotal clinical study design should be used to support a submission for a particular device. The guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. The guidance is not intended to provide a comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies. A medical device pivotal study is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use. Evidence from one or more pivotal clinical studies generally serves as the primary basis for the determination of reasonable assurance of safety and effectiveness of the medical device of a premarket approval application (PMA) and FDA’s overall risk-benefit assessment. In some cases, a PMA may include multiple studies designed to answer different scientific questions. The guidance describes principles that should be followed for the design VerDate Mar<15>2010 16:24 Nov 06, 2013 Jkt 232001 of premarket clinical studies that are pivotal in establishing the safety and effectiveness of a medical device. Practical issues and pitfalls in pivotal clinical study design are discussed, along with their effects on the conclusions that can be drawn from the studies concerning safety and effectiveness. In the Federal Register of August 15, 2011 (76 FR 50484), FDA announced the availability of the draft guidance. Interested persons were invited to comment by November 14, 2011. FDA considered the comments and revised the guidance, as appropriate. 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 pivotal clinical investigations for medical devices. 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 using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/default.htm or http://www.regulations.gov. To receive ‘‘Device Considerations for Pivotal Clinical Investigations for Medical Devices,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1776 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 0910–0120; the collections of information in 21 CFR part 812 have been approved under PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 0910–0078; the collections of information in 21 CFR part 814 have been approved under 0910–0231. 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. Dated: November 1, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26690 Filed 11–6–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 December 12, 2013, from 8 a.m. to 6:30 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel’s telephone number is 301–977–8900. Contact Person: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1643, Silver Spring, MD 20993, Sara.Anderson@fda.hhs.gov, 301 796– 7047; or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC E:\FR\FM\07NON1.SGM 07NON1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices 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 December 12, 2013, during Session I, the committee will discuss and make recommendations regarding the classification of spinal sphere devices. These devices are spheres manufactured from metallic (e.g., cobalt chromium molybdenum) or polymeric (e.g., polyetheretherketone) materials. They are intended to be inserted between the vertebral bodies into the disc space from L3–S1 to help provide stabilization and to help promote intervertebral body fusion. During the arthrodesis procedure, they are to be used with bone graft. These devices are not intended for use in motion-sparing, non-fusion procedures. Spinal sphere devices are considered preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Spinal sphere devices are currently regulated under the heading of ‘‘Intervertebral Fusion Device with Bone Graft, SolidSphere, Lumbar’’, Product Code NVR, as unclassified devices and reviewed under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness of spinal sphere devices and the regulatory classification for spinal sphere devices. On December 12, 2013, during Session II, the committee will discuss and make recommendations regarding the reclassification petition received on November 20, 2012, from DEKA Research & Development Corp. requesting that FDA reclassify stair climbing wheelchairs (21 CFR 890.3890) from Class III to Class II. A stairclimbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. On June 12, 2013 (78 FR 35173), FDA issued a proposed order which, if made final, would reclassify stair-climbing wheelchairs as Class II subject to premarket notification (510(k)) and special controls. The petitioner has one stair-climbing wheelchair approved, the iBot (P020033), and it is indicated for the following: to provide indoor and VerDate Mar<15>2010 16:24 Nov 06, 2013 Jkt 232001 outdoor mobility in confined spaces, at an elevated height, climb curbs, ascend/ descend stairs, traverse obstacles, travel over a wider variety of terrain, and negotiate uneven/inclined surfaces. Stair-climbing wheelchairs are preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Stairclimbing wheelchairs are currently regulated as Class III devices. A call for premarket approval (PMA) applications was issued on April 13, 2000 (effective July 12, 2000) (65 FR 19834). The committee’s discussion will include recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of stair-climbing wheelchairs. On December 12, 2013, during Session III, the committee will discuss and make recommendations regarding the possible reclassification of mechanical wheelchairs (21 CFR 890.3850) from Class I, currently subject to premarket notification (510(k)), to Class II, subject to special controls. The mechanical wheelchairs are being considered for exemption from premarket notification (510(k)) requirements. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. No proposed order has been issued for this proposed change in classification. Mechanical wheelchairs are preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Mechanical wheelchairs are currently regulated as Class I devices that are subject to premarket notification (510(k)) requirements (48 FR 53041). The committee will discuss whether general and/or special controls are appropriate to demonstrate a reasonable assurance of safety and effectiveness of mechanical wheelchairs and whether, if reclassified to Class II, these devices should be exempt from premarket notification (510(k)) requirements. 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 66943 available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll 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 November 21, 2013. Oral presentations will be scheduled between approximately 9:15 a.m. and 9:35 a.m. for Session I and between approximately 2:40 p.m. and 3:20 p.m. for Session II and Session III. 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 the proposed participants, and an indication of the approximate time requested to make their presentation on or before November 13, 2013. 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 November 14, 2013. Persons attending FDAs 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Clark, James.Clark@fda.hhs.gov or 301–796– 5293, 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). E:\FR\FM\07NON1.SGM 07NON1 66944 Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices Dated: November 4, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: [FR Doc. 2013–26722 Filed 11–6–13; 8:45 am] Information Collection Request Title: Scholarships for Disadvantaged Students Application and Performance Report (SDSPR); OMB No. 0915–0149— Revision BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received within 30 days of this notice. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the SUMMARY: Abstract: The purpose of the Scholarships for Disadvantaged Students (SDS) Program is to promote diversity among health profession students and practitioners by providing funds to eligible schools to provide scholarships to full-time, financially needy students from disadvantaged backgrounds enrolled in health professions and nursing programs. To qualify for participation in the SDS program, a school must be carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including students who are members of racial and ethnic minority groups (section 737(d)(1)(B) of the PHS Act). A school must meet the eligibility criteria to demonstrate that the program has achieved success based on the number and/or percentage of disadvantaged students who graduate from the school. In awarding SDS funds to eligible schools, funding points must be given to schools based on the proportion of graduate students practicing in primary care, the proportion of underrepresented minority students, and the proportion of graduates working in medically underserved communities (section 737(c) of the PHS Act). Information collected from the SDS application and SDS report is needed by the Department to determine whether applicant schools meet the statutory and regulatory requirements, to determine eligibility for program participation, and to establish priority points for funding. Applicant schools are requested to complete an application for each discipline or program. Data are provided on numbers of full-time student enrollment and the applicant schools’ racial/ethnicity data, disadvantaged fulltime enrollment by class year, full-time students graduated, full-time disadvantaged students graduated, and full-time graduates serving in Medically Underserved Communities. Numbers of full-time graduates serving in primary care must be provided only for schools of medicine, osteopathic medicine, dentistry, nursing (graduate degree program), physician assistants, dental hygiene, and mental and behavioral health. Each school will determine the eligibility of students based on financial need and whether a student is from a disadvantaged background. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Number of responses per respondent Average burden per response (in hours) Total responses Total burden hours 400 99 1 1 400 99 13 24 5,200 2,376 Total .............................................................................. tkelley on DSK3SPTVN1PROD with NOTICES SDS Application Program Specific form .............................. SDS Performance Report Form .......................................... 499 ........................ 499 ........................ 7,576 VerDate Mar<15>2010 16:24 Nov 06, 2013 Jkt 232001 PO 00000 Frm 00055 Fmt 4703 Sfmt 9990 E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66942-66944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 December 12, 2013, from 
8 a.m. to 6:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
number is 301-977-8900.
    Contact Person: Sara Anderson, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 1643, Silver Spring, MD 20993, Sara.Anderson@fda.hhs.gov, 301 
796-7047; or FDA Advisory Committee Information Line, 1-800-741-8138 
(301-443-0572 in the Washington, DC

[[Page 66943]]

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 December 12, 2013, during Session I, the committee will 
discuss and make recommendations regarding the classification of spinal 
sphere devices. These devices are spheres manufactured from metallic 
(e.g., cobalt chromium molybdenum) or polymeric (e.g., 
polyetheretherketone) materials. They are intended to be inserted 
between the vertebral bodies into the disc space from L3-S1 to help 
provide stabilization and to help promote intervertebral body fusion. 
During the arthrodesis procedure, they are to be used with bone graft. 
These devices are not intended for use in motion-sparing, non-fusion 
procedures.
    Spinal sphere devices are considered preamendment devices because 
they were in commercial distribution prior to May 28, 1976, when the 
Medical Device Amendments became effective. Spinal sphere devices are 
currently regulated under the heading of ``Intervertebral Fusion Device 
with Bone Graft, Solid-Sphere, Lumbar'', Product Code NVR, as 
unclassified devices and reviewed under the 510(k) premarket 
notification authority. FDA is seeking committee input on the safety 
and effectiveness of spinal sphere devices and the regulatory 
classification for spinal sphere devices.
    On December 12, 2013, during Session II, the committee will discuss 
and make recommendations regarding the reclassification petition 
received on November 20, 2012, from DEKA Research & Development Corp. 
requesting that FDA reclassify stair climbing wheelchairs (21 CFR 
890.3890) from Class III to Class II. A stair-climbing wheelchair is a 
device with wheels that is intended for medical purposes to provide 
mobility to persons restricted to a sitting position. The device is 
intended to climb stairs. On June 12, 2013 (78 FR 35173), FDA issued a 
proposed order which, if made final, would reclassify stair-climbing 
wheelchairs as Class II subject to premarket notification (510(k)) and 
special controls. The petitioner has one stair-climbing wheelchair 
approved, the iBot (P020033), and it is indicated for the following: to 
provide indoor and outdoor mobility in confined spaces, at an elevated 
height, climb curbs, ascend/descend stairs, traverse obstacles, travel 
over a wider variety of terrain, and negotiate uneven/inclined 
surfaces.
    Stair-climbing wheelchairs are preamendment devices because they 
were in commercial distribution prior to May 28, 1976, when the Medical 
Device Amendments became effective. Stair-climbing wheelchairs are 
currently regulated as Class III devices. A call for premarket approval 
(PMA) applications was issued on April 13, 2000 (effective July 12, 
2000) (65 FR 19834).
    The committee's discussion will include recommendations regarding 
the regulatory classifications noted above. The committee will also 
discuss whether the proposed special controls are adequate to 
reasonably ensure the safety and effectiveness of stair-climbing 
wheelchairs.
    On December 12, 2013, during Session III, the committee will 
discuss and make recommendations regarding the possible 
reclassification of mechanical wheelchairs (21 CFR 890.3850) from Class 
I, currently subject to premarket notification (510(k)), to Class II, 
subject to special controls. The mechanical wheelchairs are being 
considered for exemption from premarket notification (510(k)) 
requirements. A mechanical wheelchair is a manually operated device 
with wheels that is intended for medical purposes to provide mobility 
to persons restricted to a sitting position. No proposed order has been 
issued for this proposed change in classification.
    Mechanical wheelchairs are preamendment devices because they were 
in commercial distribution prior to May 28, 1976, when the Medical 
Device Amendments became effective. Mechanical wheelchairs are 
currently regulated as Class I devices that are subject to premarket 
notification (510(k)) requirements (48 FR 53041).
    The committee will discuss whether general and/or special controls 
are appropriate to demonstrate a reasonable assurance of safety and 
effectiveness of mechanical wheelchairs and whether, if reclassified to 
Class II, these devices should be exempt from premarket notification 
(510(k)) requirements.
    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. Scroll 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 
November 21, 2013. Oral presentations will be scheduled between 
approximately 9:15 a.m. and 9:35 a.m. for Session I and between 
approximately 2:40 p.m. and 3:20 p.m. for Session II and Session III. 
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 the proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
November 13, 2013. 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 November 14, 
2013.
    Persons attending FDAs 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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact James Clark, 
James.Clark@fda.hhs.gov or 301-796-5293, 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).


[[Page 66944]]


    Dated: November 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-26722 Filed 11-6-13; 8:45 am]
BILLING CODE 4160-01-P