18828 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 

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 statutes 

and regulations. 

II. 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. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: March 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7456 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0577] 

Guidance for Industry and Food and 

Drug Administration Staff; Factors To 

Consider When Making Benefit-Risk 

Determinations in Medical Device 

Premarket Approval and de Novo 

Classifications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance document 

entitled ‘‘Factors to Consider When 

Making Benefit-Risk Determinations in 

Medical Device Premarket Approval and 

De Novo Classifications.’’ This guidance 

is intended to provide greater clarity on 

FDA’s decisionmaking process with 

regard to benefit-risk determinations in 

the premarket review of medical devices 

in the premarket approval and de novo 

pathways. 

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: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Factors to Consider When 

Making Benefit-Risk Determinations in 

Medical Device Premarket Approval and 

De Novo Classifications’’ 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 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 

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: Ruth 

Fischer, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4424, Silver Spring, 

MD 20993–0002, 301–796–5735. 

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 

assessing the probable benefit of a 

device versus its probable risk. This 

guidance sets out the principal factors 

FDA considers when making this 

determination and explains them in 

detail. This 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. 

The factors described in this guidance 

apply to devices submitted under 

premarket approval applications and de 

novo petitions. 

This guidance also includes a 

worksheet that reviewers will use in 

making benefit-risk determinations for 

applicable devices. The worksheet is 

attached as Appendix B to the guidance, 

and examples of how reviewers might 

use the worksheet are attached as 

Appendix C 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. 

In the Federal Register of August 15, 

2011 (76 FR 50483), 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 factors to consider 

when making benefit-risk 

determinations in medical device 

premarket approval and de novo 

classifications. 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 is available 

for all CDRH guidance documents 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 Approval and 

De Novo Classifications’’ 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 concludes that this guidance 

contains no new collections of 

information. The guidance refers to 

currently approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 18829 

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. 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: March 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7418 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–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 May 10 and 11, 2012, from 8 

a.m. to 6 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: Avena Russell, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

1535, Silver Spring, MD 20993–0002, 

Avena.Russell@fda.hhs.gov, 301–796– 

3805, 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. 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 and call the 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On May 10 and 11, 2012, the 

committee will discuss general issues 

related to medical devices intended for 

obese patients. The committee will 

provide recommendations regarding 

trial design for clinical studies to 

evaluate the safety and effectiveness of 

weight loss devices placed either 

endoscopically (balloons and suture 

devices) or laparoscopically (bands, 

space-occupying devices, etc.) and 

contrast those to surgery. Additional 

discussion will include issues 

pertaining to clinically meaningful 

weight loss, when the primary endpoint 

should be measured, length of patient 

followup, and how much risk is 

acceptable for a potentially small 

amount of weight loss. 

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 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 April 27, 2012. Oral 

presentations from the public will be 

scheduled on May 10, 2012 between 

approximately 12:30 p.m. and 2 p.m. 

and on May 11, 2012 between 

approximately 11 a.m. and 12 p.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 April 19, 2012. 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 April 20, 2012. 

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 physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact James Clark, 

Conference Management Staff, at 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). 

Dated: March 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7406 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0001] 

Circulatory System 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: Circulatory 

System Devices Panel of the Medical 

Devices Advisory Committee. 


tkelley on DSK3SPTVN1PROD with NOTICES