Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.” The purpose of this guidance is to provide institutional review boards (IRBs), industry, clinical investigators, and FDA staff with factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an investigational device exemption (IDE) application. This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation.
The announcement of the guidance is published in the Federal Register on July 11, 2019.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Start Printed Page 33076Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2014-D-0331 for “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
- Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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 guidance document entitled “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials” to the Office of Policy, 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.
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FOR FURTHER INFORMATION CONTACT:
John Doucet, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301-796-6474.
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A live case presentation is a live or pre-recorded broadcast of a surgical or percutaneous procedure, typically narrated by the operator (or a discussant other than the operator), with or without expert panel and/or audience interaction. Our expectation is that very few investigations under an IDE will include live case presentations. However, by increasing awareness of the study for healthcare professionals and eligible subjects, live case presentations may lead to new therapies being made available sooner.
This guidance is intended, in part, to improve the quality of information about live case presentations submitted by sponsors as part of an investigational plan in an original IDE application or supplement to an IDE application, or to the IRB for non-significant risk studies, and to ensure consistency in the review of those submissions. It describes measures we recommend sponsors take to ensure adequate human subject protection, followup, reporting, and data analysis for live case presentations.
FDA considered comments received on the draft guidance that appeared in the Federal Register of April 17, 2014 (79 FR 21776). FDA revised the guidance as appropriate in response to the comments.
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 current thinking of FDA on live case presentations during IDE clinical trials. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is 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” 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 guidance refers to previously approved collections of information. 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 the following FDA regulations have been approved by OMB as listed in the following table:
|21 CFR part||Topic||OMB control No.|
|812||Investigational Device Exemption||0910-0078|
|50, 56||Protection of Human Subjects: Informed Consent; Institutional Review Boards||0910-0755|
|56||Institutional Review Boards||0910-0130|
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Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14765 Filed 7-10-19; 8:45 am]
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