Live Case Presentations During Investigational Device Exemption Clinical Trials; Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff; Availability, 21776-21777 [2014-08710]

Download as PDF 21776 Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices [FR Doc. 2014–08706 Filed 4–16–14; 8:45 am] TKELLEY on DSK3SPTVN1PROD with NOTICES BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0331] Live Case Presentations During Investigational Device Exemption Clinical Trials; Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Mar<15>2010 17:28 Apr 16, 2014 Jkt 232001 PO 00000 Notice. Frm 00066 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff.’’ This guidance is intended, in part, to improve the quality of information submitted by sponsors in an IDE application or supplement to an IDE application and to ensure consistency in the review of those submissions. This draft guidance is intended to clarify FDA’s regulations and policies regarding live case SUMMARY: E:\FR\FM\17APN1.SGM 17APN1 EN17AP14.005</GPH> Dated: April 11, 2014. Leslie Kux, Assistant Commissioner for Policy. Federal Register / Vol. 79, No. 74 / Thursday, April 17, 2014 / Notices TKELLEY on DSK3SPTVN1PROD with NOTICES presentations using unapproved or uncleared investigational devices in the United States. This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 16, 2014. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request. 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: Sheila Brown, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993–0002, 301–796–6563, sheila.brown@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Requests for live case presentations have been submitted to the Agency as multiple supplements to an approved IDE application as either protocol deviations, changes to the investigational plan, or study expansion requests. Live case presentations have not generally been prospectively identified and described as components of the overall study design in original IDE applications. Although it is expected that very few investigations conducted under an IDE will have the need for live case VerDate Mar<15>2010 17:28 Apr 16, 2014 Jkt 232001 presentations, FDA has seen an increase in the number of requests for certain investigations to conduct live case presentations. Live case presentations may increase awareness of the study for potential investigators and facilitate the recruitment of subjects. Increased awareness of the IDE clinical study by other health care professionals resulting from a live case presentation might accelerate enrollment of eligible subjects which, in turn, may lead to new therapies being made available sooner. However, because of concerns related to human subject protection and uncertainty about potential differences between outcomes of subjects participating in live case presentations compared to subjects not participating in live case presentations, this guidance was developed for institutional review boards, review staff, the regulated industry and clinical community. 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 live case presentations during IDE clinical trials. 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 downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff,’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1736 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 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 21777 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 812 have been approved under OMB control number 0910–0078. 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: April 11, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–08710 Filed 4–16–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0332] Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices; Draft Guidance for Industry 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 draft guidance entitled ‘‘Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.’’ National outbreaks of Toxic Anterior Segment Syndrome (TASS) have been associated with single-use intraocular ophthalmic devices (IODs) and singleuse intraocular ophthalmic surgical instruments/accessories that are contaminated with endotoxins. These devices can become contaminated as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions (510(k)s) for different categories of IODs SUMMARY: E:\FR\FM\17APN1.SGM 17APN1

Agencies

[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21776-21777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08710]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0331]


Live Case Presentations During Investigational Device Exemption 
Clinical Trials; Draft Guidance for Institutional Review Boards, 
Industry, Investigators, 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 draft guidance entitled ``Live Case Presentations 
During Investigational Device Exemption (IDE) Clinical Trials: Draft 
Guidance for Institutional Review Boards, Industry, Investigators, and 
Food and Drug Administration Staff.'' This guidance is intended, in 
part, to improve the quality of information submitted by sponsors in an 
IDE application or supplement to an IDE application and to ensure 
consistency in the review of those submissions. This draft guidance is 
intended to clarify FDA's regulations and policies regarding live case

[[Page 21777]]

presentations using unapproved or uncleared investigational devices in 
the United States. 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 July 16, 2014.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Live Case Presentations During Investigational Device Exemption (IDE) 
Clinical Trials: Draft Guidance for Institutional Review Boards, 
Industry, Investigators, and Food and Drug Administration Staff'' to 
the Office of the Center Director, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.
    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: Sheila Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993-0002, 301-796-6563, 
sheila.brown@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Requests for live case presentations have been submitted to the 
Agency as multiple supplements to an approved IDE application as either 
protocol deviations, changes to the investigational plan, or study 
expansion requests. Live case presentations have not generally been 
prospectively identified and described as components of the overall 
study design in original IDE applications.
    Although it is expected that very few investigations conducted 
under an IDE will have the need for live case presentations, FDA has 
seen an increase in the number of requests for certain investigations 
to conduct live case presentations. Live case presentations may 
increase awareness of the study for potential investigators and 
facilitate the recruitment of subjects. Increased awareness of the IDE 
clinical study by other health care professionals resulting from a live 
case presentation might accelerate enrollment of eligible subjects 
which, in turn, may lead to new therapies being made available sooner. 
However, because of concerns related to human subject protection and 
uncertainty about potential differences between outcomes of subjects 
participating in live case presentations compared to subjects not 
participating in live case presentations, this guidance was developed 
for institutional review boards, review staff, the regulated industry 
and clinical community.

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 live case 
presentations during IDE clinical trials. 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 downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Live Case Presentations 
During Investigational Device Exemption (IDE) Clinical Trials: Draft 
Guidance for Institutional Review Boards, Industry, Investigators, and 
Food and Drug Administration Staff,'' may send an email request to 
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the 
document. Please use the document number 1736 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 812 have been approved under 
OMB control number 0910-0078.

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: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08710 Filed 4-16-14; 8:45 am]
BILLING CODE 4160-01-P
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