Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability, 50484-50485 [2011-20603]

Download as PDF 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: 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. 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 This draft guidance sets out the factors FDA considers when making this determination and explains them in detail. This draft guidance also gives examples of how the factors interrelate and how they may affect FDA’s decisions.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 This draft guidance also includes for public comment a draft worksheet that reviewers may use in making benefitrisk determinations.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. FDA tentatively concludes that this draft guidance contains no new collections of information. This draft guidance refers to currently approved collections of information found in FDA regulations.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. srobinson on DSK4SPTVN1PROD with NOTICES 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 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 VerDate Mar<15>2010 16:05 Aug 12, 2011 Jkt 223001 IV. Paperwork Reduction Act of 1995 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: PO 00000 Notice. Frm 00034 Fmt 4703 Sfmt 4703 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. SUMMARY: 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. DATES: 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 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. ADDRESSES: 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. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\15AUN1.SGM 15AUN1 Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices srobinson on DSK4SPTVN1PROD with NOTICES 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). VerDate Mar<15>2010 16:05 Aug 12, 2011 Jkt 223001 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available from CBER at https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm or on the Division of Dockets Management Internet site at https://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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 50485 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 E:\FR\FM\15AUN1.SGM 15AUN1

Agencies

[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Notices]
[Pages 50484-50485]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20603]


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

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 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:  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.

[[Page 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available from CBER at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or on the Division of Dockets Management Internet site at 
https://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
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