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, 18828-18829 [2012-7418]

Download as PDF 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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. 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. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:29 Mar 27, 2012 Jkt 226001 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 https://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: ADDRESSES: 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at either https://www.regulations.gov or https://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 E:\FR\FM\28MRN1.SGM 28MRN1 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 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. tkelley on DSK3SPTVN1PROD with NOTICES 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– VerDate Mar<15>2010 17:29 Mar 27, 2012 Jkt 226001 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 https://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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 18829 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 https://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. E:\FR\FM\28MRN1.SGM 28MRN1

Agencies

[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18828-18829]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7418]

-----------------------------------------------------------------------

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 https://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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at either https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/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

[[Page 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

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