50484 Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5449, Silver Spring, 

MD 20993–0002, 301–796–5094. 

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 

There are many factors that go into 

weighing the probable benefit of a 

device versus its probable risk. This 

draft guidance sets out the factors FDA 

considers when making this 

determination and explains them in 

detail. This draft guidance also gives 

examples of how the factors interrelate 

and how they may affect FDA’s 

decisions. By clarifying FDA’s 

decisionmaking process in this way, we 

hope to improve the predictability, 

consistency, and transparency of the 

review process for applicable devices. 

This draft guidance also includes for 

public comment a draft worksheet that 

reviewers may use in making benefitrisk determinations. The worksheet is 

attached as appendix A to the guidance. 

This level of documentation is very 

helpful to maintaining the consistency 

of review across the different review 

divisions and better assuring that an 

appropriate decision is reached. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This draft guidance, when finalized, 

will represent the Agency’s current 

thinking on factors to consider when 

making benefit-risk determinations in 

medical device premarket review. 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of the draft guidance may do so by using 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 

at either http://www.regulations.gov or 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm. To 

receive ‘‘Factors to Consider When 

Making Benefit-Risk Determinations in 

Medical Device Premarket Review’’ 

from CDRH, 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 1772 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no new 

collections of information. This draft 

guidance refers to currently 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 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 10, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20652 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–D–0567] 

Draft Guidance for Industry, Clinical 

Investigators, and Food and Drug 

Administration Staff; Design 

Considerations for Pivotal Clinical 

Investigations for Medical Devices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Design Considerations for 

Pivotal Clinical Investigations for 

Medical Devices.’’ This 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. This 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. This draft guidance 

is not final nor is it in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 14, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Design 

Considerations for Pivotal Clinical 

Investigations for Medical Devices’’ to 

the Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health (CDRH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4613, Silver Spring, 

MD 20993–0002, or to the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist that office in 

processing your request, or fax your 

request to 301–847–8149. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit electronic comments on the 

draft 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: Greg 

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. 


srobinson on DSK4SPTVN1PROD with NOTICES
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