Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff; Availability, 66941-66942 [2013-26690]

Download as PDF Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices Submit written requests for single copies of the draft guidance document entitled ‘‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002. 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 Submit electronic comments on the draft guidance to https:// www.regulations.gov.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: Eric A. Mann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2438, Silver Spring, MD 20993–0002, 301–796–5620. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: 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 Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the definitions and regulatory requirements for hearing aids and PSAPs. 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 Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet.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 https://www.regulations.gov. To receive ‘‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products’’ 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 1832 to identify the guidance you are requesting. tkelley on DSK3SPTVN1PROD with NOTICES I. Background IV. Paperwork Reduction Act of 1995 Since issuance of the February 25, 2009 guidance entitled, ‘‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products’’ FDA has become aware of a lack of clarity regarding how the Agency defines a hearing aid versus a personal sound amplification product (PSAP), which has also led, in some cases, to inappropriate application of regulatory requirements for such products. These inconsistent interpretations of the definitions may inadvertently result in hearing-impaired consumers bypassing safeguards that were implemented to promote the prompt diagnosis of treatable medical conditions causing hearing loss. To ensure consistent interpretation, consistent application of relevant regulatory requirements, and adequate protection of the public health, FDA seeks to further clarify the definitions of hearing aids and PSAPs. This draft guidance, when finalized, will supersede the guidance entitled ‘‘Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,’’ dated February 25, 2009. 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 801 have been approved under OMB control number 0910–0485; and the collections of information in 21 CFR part 807 subpart E have been approved under OMB control number 0910–0120. VerDate Mar<15>2010 16:24 Nov 06, 2013 Jkt 232001 V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https:// www.regulations.gov. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 66941 Dated: November 1, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26691 Filed 11–6–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0567] Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the 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. 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 ‘‘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 the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to CDRH at 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. SUMMARY: E:\FR\FM\07NON1.SGM 07NON1 66942 Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices tkelley on DSK3SPTVN1PROD with NOTICES 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: Gregory 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 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 20852–1448, 301–827–6210. I. Background The guidance document is intended to provide guidance to those involved in designing clinical studies that support premarket submissions for medical devices and 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 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 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 guidance describes principles that should be followed for the design VerDate Mar<15>2010 16:24 Nov 06, 2013 Jkt 232001 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. In the Federal Register of August 15, 2011 (76 FR 50484), 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 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 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 https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/default.htm or https://www.regulations.gov. To receive ‘‘Device Considerations for Pivotal Clinical Investigations for Medical Devices,’’ 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 1776 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This 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 0910–0120; the collections of information in 21 CFR part 812 have been approved under PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 0910–0078; the collections of information in 21 CFR part 814 have been approved under 0910–0231. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https:// www.regulations.gov. Dated: November 1, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26690 Filed 11–6–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 December 12, 2013, from 8 a.m. to 6:30 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: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1643, Silver Spring, MD 20993, Sara.Anderson@fda.hhs.gov, 301 796– 7047; or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66941-66942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26690]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0567]

Design Considerations for Pivotal Clinical Investigations for
Medical Devices; Guidance for Industry, Clinical Investigators,
Institutional Review Boards and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the 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.

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 ``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 the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to CDRH at 301-847-8149.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.

[[Page 66942]]

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: Gregory 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 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 20852-1448, 301-827-6210.

I. Background

The guidance document is intended to provide guidance to those
involved in designing clinical studies that support premarket
submissions for medical devices and 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 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 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 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.
In the Federal Register of August 15, 2011 (76 FR 50484), 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 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 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 https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. To receive ``Device
Considerations for Pivotal Clinical Investigations for Medical
Devices,'' 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
1776 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This 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 0910-0120; the collections of information in 21 CFR part
812 have been approved under 0910-0078; the collections of information
in 21 CFR part 814 have been approved under 0910-0231.

V. Comments

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https://www.regulations.gov.

Dated: November 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26690 Filed 11-6-13; 8:45 am]
BILLING CODE 4160-01-P

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