Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices 50485 

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, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance document is 

intended to provide guidance to those 

involved in designing clinical studies 

intended to support premarket 

submissions for medical devices and for 

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 The draft guidance document 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 The draft guidance is 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The draft guidance describes 

principles that should be followed for 

the design 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. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on design considerations for 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 draft 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 

from CBER at http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm or on the Division of 

Dockets Management Internet site at 

http://www.regulations.gov. To receive 

‘‘Design Considerations for Pivotal 

Clinical Investigations for Medical 

Devices,’’ you may either send an e-mail 

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 draft 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; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

Dated: August 9, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20603 Filed 8–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Obstetrics and Gynecology Devices 

Panel of the Medical Devices Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the Obstetrics 

and Gynecology Devices Panel of the 

Medical Devices Advisory Committee. 

This meeting was announced in the 

Federal Register of July 14, 2011 (76 FR 

41507). The amendment is being made 

to reflect a change in the Procedure 

portion of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: 

Shanika Craig, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1613, Silver Spring, 

MD 20993–0002, 301–796–6639, 

Shanika.Craig@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 14, 2011, FDA 

announced that a meeting of the 

Obstetrics and Gynecology Devices 

Panel of the Medical Devices Advisory 

Committee would be held on September 

8 and 9, 2011. On page 41508, in the 

first column, the Procedure section is 

changed to add, directly after the first 

full paragraph, the following paragraph: 

FDA will work with the 

manufacturers of surgical mesh 

products who wish to make 

presentations to ensure that adequate 

time, separate from the 10 a.m. to 11 

a.m. time slots from the general open 

public hearing, is provided. 

Manufacturers interested in making 

formal presentations to the committee 

should notify the contact person on or 


srobinson on DSK4SPTVN1PROD with NOTICES
50486 Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices 

before August 22, 2011. Manufacturers 

with common interest are urged to 

coordinate their oral presentations. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: August 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20644 Filed 8–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Inherited 

Disease Research Access Committee. 

Date: September 9, 2011. 

Time: 11:30 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Camilla E. Day, PhD, 

Scientific Review Officer, CIDR, National 

Human Genome Research Institute, National 

Institutes of Health, 5635 Fishers Lane, Suite 

4075, Bethesda, MD 20892, 301–402–8837, 

camilla.day@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: August 9, 2011. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–20688 Filed 8–12–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors, National 

Human Genome Research Institute. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intramural 

programs and projects conducted by the 

National Human Genome Research 

Institute, including consideration of 

personnel qualifications and 

performance, and the competence of 

individual investigators, the disclosure 

of which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Board of Scientific 

Counselors, National Human Genome 

Research Institute. 

Date: September 26–27, 2011. 

Time: September 26, 2011, 8 a.m. to 7 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 50, Fifth Floor Conference Room, 50 

Center Drive, Bethesda, MD 20892. 

Time: September 27, 2011, 8 a.m. to 4 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 50, Fifth Floor Conference Room, 50 

Center Drive, Bethesda, MD 20892. 

Contact Person: Claire Kelso, Intramural 

Program Specialist, Division of Intramural 

Research, Office of the Scientific Director, 

National Human Genome Research Institute, 

50 South Drive, Building 50, Room 5222, 

Bethesda, MD 20892–8002, 301 435–5802, 

claire@nhgri.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: August 9, 2011. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–20687 Filed 8–12–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Oncology 

AREA Review. 

Date: September 15–16, 2011. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Manzoor Zarger, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6208, 

MSC 7804, Bethesda, MD 20892, (301) 435– 

2477, zargerma@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group; Clinical Neuroplasticity and 

Neurotransmitters Study Section. 

Date: September 19–20, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Westin Seattle, 1900 Fifth 

Avenue, Seattle, WA 98101. 

Contact Person: Suzan Nadi, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217B, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1259, nadis@csr.nih.gov. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group; 

Behavioral Medicine, Interventions and 

Outcomes Study Section. 

Date: September 26–27, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: W Chicago Lakeshore, 644 North 

Lakeshore Drive, Chicago, IL 60611. 

Contact Person: Lee S. Mann, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3186, 

MSC 7848, Bethesda, MD 20892, 301–435– 

0677, mannl@csr.nih.gov. 


srobinson on DSK4SPTVN1PROD with NOTICES