Contains Nonbinding Recommendations 
Live Case Presentations During 
Investigational Device Exemption 
(IDE) Clinical Trials 
Guidance for Institutional Review 
Boards, Industry, Clinical 
Investigators, and Food and Drug 
Administration Staff 
Document issued on July 11, 2019. 
The draft of this document was issued on April 17, 2014. 
For questions about this document, contact the Office of Clinical Evidence and Analysis, 
DCEA1: Division of Clinical Science and Quality at CDRHClinicalEvidence@fda.hhs.gov. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852. Identify all comments with the docket number FDA-2014-D-0331. Comments may not 
be acted upon by the Agency until the document is next revised or updated. 
Additional Copies 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the 
document number 1736 and complete title of the guidance in the request.  Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction .................................................................................................................... 1 
II.  Background .................................................................................................................... 3 
III.  Human Subject Protection Measures ............................................................................. 3 
A.  Risk Analysis .................................................................................................................3 
B.  Informed Consent...........................................................................................................4
C.  Additional Considerations for Children .........................................................................6 
IV.  Information to Include in IDE Applications When Seeking to Conduct Live Case 
Presentations ............................................................................................................................. 6 
V.  Data Collection and Reporting ....................................................................................... 9 
VI.  Conclusion ................................................................................................................... 10  Contains Nonbinding Recommendations 
Live Case Presentations During 
Investigational Device Exemption 
(IDE) Clinical Trials 
Guidance for Institutional Review 
Boards, Industry, Clinical 
Investigators, and Food and Drug 
Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic. 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. To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page. 
I. Introduction 
The purpose of this document is to provide Institutional Review Boards (IRBs), industry, 
clinical investigators, and Food and Drug Administration (FDA) staff factors to consider 
when evaluating the appropriateness of a live case presentation within a clinical 
investigation1 conducted under an investigational device exemption (IDE) application.2 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. Applications and supplements that include a live case presentation are referred 
to generally as requests throughout this document. 
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. These presentations are typically broadcast 
at scientific meetings to increase awareness of the clinical investigation and recruit 
                                                          
1 For purposes of this guidance, the terms clinical investigation, investigation, study, and research are 
used synonymously. 
2 Although this guidance is written primarily for device investigations that require submission of an IDE 
application to FDA (e.g., significant risk devices), the information may also be applied to non-significant risk 
(NSR) device studies. 
1  Contains Nonbinding Recommendations 
prospective investigators and study subjects. Video recordings or broadcasts that are outside 
the scope of this guidance include devices or procedures that automatically capture video 
during use (e.g., laparoscopic and thorascopic devices), telemedicine, and recordings that are 
routinely captured and broadcast as part of an institutions standard policies. Investigators 
should follow the institutions policies regarding the ability to share these kinds of video 
recordings in a manner consistent with applicable laws and regulations.3
Our expectation is that very few investigations under an IDE will include live case 
presentations. However, by increasing awareness of the study for health care professionals 
and eligible subjects, live case presentations may lead to new therapies being made available 
sooner. Because live case presentations are often intended to recruit investigators and 
subjects, it is generally not appropriate to request a live case presentation for a clinical 
investigation nearing completion, though exceptions may exist. 
Not all clinical investigations are appropriate for live case presentations. For example, certain 
high-risk procedures that may adversely impact the subject, or certain investigations 
involving children, may not be suitable for live case presentations. When reviewing an IDE 
application, FDA intends to evaluate whether the requested live case presentation raises the 
risk profile of participation for subjects, such that conducting the live case presentation is not 
justified. A live case presentation may not be appropriate for novel devices for which the risk 
profile is unknown or only limited information is available. On the other hand, an acceptable 
live case presentation could include a high-risk procedure in which the risks are well-
understood, risk mitigations are in place (e.g., the case is being performed by a team of 
operators with high levels of expertise at a site with an excellent record of both performing 
the procedure and performing live case presentations), subjects are selected with appropriate 
clinical and anatomic characteristics (e.g., a subject that does not have complex anatomy or is 
not at the highest risk for injury should a complication occur), and the informed consent 
process is conducted in accordance with 21 CFR part 50. 
Investigations involving a significant risk device,4 including those investigations involving 
live case presentations, require prior approval by FDA and an IRB (21 CFR 812.20(a)(2) and 
21 CFR 812.62). Investigations involving a non-significant risk device, including those 
investigations involving live case presentations, must be approved by an IRB, but non-
significant risk device investigations generally do not require the submission of an IDE 
application to FDA (21 CFR 812.2(b)(1)(ii)). 
                                                          
3 Additional federal statutes or regulations, administered by FDA or other federal agencies, not mentioned 
herein are outside of the scope of this guidance, but may apply to clinical investigations, including live case 
presentations. 
4 A significant risk device is defined as an investigational device that: (1) is intended as an implant and presents 
a potential for serious risk to the health, safety, or welfare of a subject; (2) is purported or represented to be for a 
use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or 
welfare of a subject; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the 
health, safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to the health, safety, 
or welfare of a subject (21 CFR 812.3(m)). 
2 Contains Nonbinding Recommendations 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidance means that 
something is suggested or recommended, but not required. 
II.  Background 
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 and to ensure consistency in the review of 
requests to include live case presentations. It describes measures we recommend sponsors 
take to ensure adequate human subject protection, follow-up, reporting, and data analysis for 
live case presentations. Because there are unique safety considerations, and possible 
differences between outcomes of subjects participating in live case presentations compared to 
subjects not participating in live case presentations, this guidance was developed for IRBs, 
industry, clinical investigators, and FDA review staff to support best practices. 
III.  Human Subject Protection Measures 
FDA and IRBs consider the adequacy of human subject protection measures when reviewing 
an investigation involving a live case presentation. Investigations involving live case 
presentations conducted under 21 CFR part 812, which may include investigations involving 
significant risk and non-significant risk devices, must be reviewed and approved by an IRB 
before they begin (21 CFR 812.62). The general standards for the composition, operation, 
and responsibility of IRBs that review FDA-regulated clinical investigations are outlined in 
21 CFR part 56. The criteria for IRB approval of research, including research involving live 
case presentations of investigational devices, are outlined in 21 CFR 56.111. Among the 
approval criteria that may present particularly important questions for the IRB when 
evaluating an investigation involving live case presentations are the following: 
1.  Risks to human subjects are minimized in accordance with 21 CFR 56.111(a)(1); 
2.  Informed consent will be sought in accordance with and to the extent required by 21 
CFR part 50 (21 CFR 56.111(a)(4)); 
3.  Where appropriate, there are adequate provisions to protect the privacy of subjects 
and to maintain the confidentiality of data (21 CFR 56.111(a)(7)); and 
4.  When some or all of the subjects are children, the research complies with 21 CFR part 
50, subpart D (21 CFR 56.111(c)). 
A. Risk Analysis 
IDE applications submitted to FDA must include an investigational plan with a risk analysis 
under 21 CFR 812.20(b)(2) and 21 CFR 812.25(c). A modified risk analysis is likely needed 
when an investigational plan is revised to include a live case presentation and submitted as a 
supplement to the original IDE application. Reasonable efforts should be undertaken to 
identify and discuss in detail all probable risks and benefits of conducting the procedure as a 
live case presentation. The risk analysis should describe and analyze all increased risks to 
which the subject will be exposed by participating in a live case presentation, discuss the 
3 Contains Nonbinding Recommendations 
manner in which these risks will be minimized, and provide a justification for the live case 
presentation consistent with 21 CFR 812.25(c). 
Live case presentations may increase risks to subjects in several ways.5 The potential 
additional risks that should be addressed in the original or modified investigational plan may 
include, but are not limited to, the following: 
  Increased risk of infection due to the increased number of non-medical personnel 
and broadcast equipment in the sterile environment of the operating room or 
procedure room; 
  Prolongation of the medical procedure, resulting in increased blood loss, 
anesthesia time, radiation exposure, and risk of infection; 
  Distraction of the operator and other medical personnel from the highly technical 
and/or high-risk procedure, which could negatively impact the procedure results; 
  Increased pressure on the operator as a result of public scrutiny of the procedure, 
or conflicting advice from a panel of experts moderating the live case session, 
which could negatively impact the procedure results; 
  Invasion of the subjects privacy in the operating room or procedure room 
because of the presence of persons not directly involved in medical care, as well 
as the public viewing of the subjects medical procedure; and 
  Inadvertent broadcasting of the subject, subject identifiers, the subjects voice, or 
conversations in which the subjects identity is revealed. 
A subject who agrees to participate in a live case presentation should have the same 
anticipated benefit as if that subject was participating in the clinical investigation and did not 
participate in the live case demonstration. 
During a live case presentation that is being recorded and/or broadcasted in real time, a 
discussant/narrator, other than the operating surgeon, should participate to explain the 
procedure and answer questions. This recommendation is intended to reduce the risk of 
prolonging the procedure or distracting the surgeon performing the procedure. If the sponsor 
does not elect to use a discussant/narrator, this should be specified when the request for a live 
case presentation is submitted to the FDA in the original IDE application or supplement to an 
IDE application; this information should also be included in the submission to the reviewing 
IRB. In addition, FDA would expect to see the sponsors rationale for not having a 
discussant/narrator other than the operating surgeon and any procedures that would be 
employed to help mitigate the potential risk of not using a separate discussant/narrator. FDA 
recommends recording the procedure to minimize the number of live case presentations 
conducted during the clinical investigation. 
B. Informed Consent 
A subject may be asked to participate in a live case presentation after enrolling in a study. It 
must be made clear to the subject that participation in a live case presentation is optional (see 
                                                          
5 Sade RM, for the American Association for Thoracic Surgery Ethics Committee and The Society of Thoracic 
Surgeons Standards and Ethics Committee. Broadcast of Surgical Procedures as a Teaching Instrument in 
Cardiothoracic Surgery, J Thorac Cardiovasc Surg 2008; 136:273-7. 
4 Contains Nonbinding Recommendations 
21 CFR 50.25(a)(8)). FDA recommends that the informed consent incorporate a statement 
that there is no additional direct benefit beyond the benefits of the clinical investigation, if 
any, conferred on the subject by his or her participation in the live case presentation. It 
should also be made clear to the subject that there will be no favoritism from the investigator 
as an acknowledgement or reward for consenting to participate in a live case presentation. 
The informed consent document and process must comply with the requirements of 21 CFR 
50.20 and minimize the possibility of coercion or undue influence for subjects who are asked 
to participate in a live case presentation. Subjects should be able to enroll and continue their 
participation in the investigation without agreeing to participate in a live case presentation. 
Legally effective informed consent for a subjects participation in a live case presentation 
must be obtained in accordance with 21 CFR part 50. The informed consent for a live case 
presentation may be a separate document, in which case, it should clearly outline any 
differences between the live case procedure and the study protocol. This separate document 
must include a description of any reasonably foreseeable risks, including any risks 
specifically associated with the live case presentation and any confidentiality/privacy risks 
pursuant to 21 CFR 50.25(a). A subject who participates in a live case presentation must be 
informed (typically in writing) by the investigator (or a person designated by the 
investigator) of these risks and of the investigational nature of the device pursuant to 21 CFR 
50.27 and 21 CFR 50.25. The informed consent for a live case presentation should describe, 
where applicable: 
1.  Whether the procedure will be recorded for future viewing and/or broadcast to 
an audience during the conduct of the procedure; 
2.  That there is no additional direct benefit to the subject for participating in the 
live case presentation beyond the benefits of the clinical investigation, if any; 
3.  That it is not known whether participating in a live case presentation will 
affect clinical outcome compared to subjects who do not participate; 
4.  Any additional or increased risks posed by performing the procedure as a live 
case presentation, such as risks posed by increased anesthesia and/or 
procedure time, compared to the procedure not being performed as a live case 
presentation (see previous discussion under Risk Analysis); 
5.  Any additional or increased risks related to subject confidentiality that may 
occur as a result of participation in the live case presentation, such as privacy 
concerns related to the live case presentation broadcast, and subsequent 
distribution and/or use of a video or other type of stored media of the 
procedure; and 
6.  Whether additional follow-up and evaluation may be warranted as a result of 
the subjects participation in a live case presentation and how such follow-up 
and evaluation may be different compared to the procedure not being 
performed as a live case presentation. 
For significant risk studies, informed consent documents must be included in the original 
IDE application or supplement to an IDE application (21 CFR 812.20(b)(11)). The informed 
consent document(s) must be approved by the FDA and the IRB prior to beginning such a 
study or beginning the live case presentation (21 CFR 812.42). For nonsignificant risk 
5 Contains Nonbinding Recommendations 
studies, the informed consent document must be approved by the IRB (21 CFR 56.109(a); 21 
CFR 812.2(b)(1)(ii)). 
C. Additional Considerations for Children 
The Agency believes there will only be rare instances in which it might be appropriate to 
have live case presentations of children.6 Live case presentations involving children should 
be reviewed by the IRB with particular concern for additional risks to the safety of the 
children during the procedure. In addition to the risks described in Section III.A, these live 
case presentations pose unique considerations. For example, children are smaller than adults 
on average, which may make the procedure involved more technically challenging. Safe 
performance of the procedure may therefore require a heightened degree of concentration, 
which may be more difficult to achieve given the distractions that may be associated with 
live case presentations. 
In addition to other responsibilities assigned to IRBs under 21 CFR parts 50 and 56, each 
IRB must review clinical investigations involving children as subjects covered by 21 CFR 
part 50, subpart D and approve only those clinical investigations that satisfy the criteria 
described in 21 CFR 50.51, 50.52, or 50.53, and the conditions of all other applicable 
sections of 21 CFR part 50, subpart D (21 CFR 50.50 and 21 CFR 56.111(c)). The added risk 
of a live case presentation should present no more than minimal risk to the child. In addition, 
the IRB must determine that adequate provisions are made for soliciting the assent of the 
child when, in the judgment of the IRB, the child is capable of providing assent and that the 
permission of their parents or guardians is granted as set forth in 21 CFR 50.55. 
IV.  Information to Include in IDE Applications When 
Seeking to Conduct Live Case Presentations 
FDA believes live case presentations performed during an investigation may affect the rights, 
safety or welfare of subjects enrolled in the clinical trial. Therefore, for investigations of 
significant risk devices conducted under an approved IDE, the sponsor of the investigation 
must obtain FDA approval of changes to the investigational plan per 21 CFR 812.35(a) and 
IRB approval per 21 CFR 812.62 prior to conducting a live case presentation (21 CFR 
812.42). For investigations of non-significant risk devices, sponsors must obtain IRB 
approval per 21 CFR 812.2(b)(1)(ii) prior to changing the investigation to include a live case 
presentation. 
Live case presentations have not generally been prospectively identified and described as 
components of the overall study design in original IDE applications. Requests for live case 
presentations have been submitted to the FDA as various supplements to an approved IDE 
application such as prospective requests for protocol deviations, changes to the 
investigational plan, or study expansion requests in accordance with 21 CFR 812.35(a). We 
recommend that the IDE supplement adding a live case presentation to the investigation be 
identified as a request for a live case demonstration. 
                                                          
6 For the purposes of this guidance, FDA has adopted the term children as defined in 21 CFR 50.3(o). 
6 Contains Nonbinding Recommendations 
Sponsors should consider whether they intend to conduct live case presentations early in 
development and include relevant information in the investigational plan section of the 
original IDE, where possible (see 21 CFR 812.25). The inclusion of live cases in a study may 
affect the overall study design, including the scientific soundness of the study and the way 
the data are analyzed. For example, subjects may be pre-selected to participate in the 
broadcast, which may result in breaking treatment assignment protocols, unblinding 
investigators and subjects, and introducing selection bias. Even if the study is designed as a 
single arm study, the live case presentation may represent a change to the approved research 
since there may be additional anesthesia time or other additional risks. Subjects may 
experience changes in treatment regimen or have their privacy compromised. Data analysis, 
risk analysis, and reporting may also be altered. Therefore, if live case presentations are 
anticipated for any part of an investigation at the time an original IDE application is 
submitted, the plan for the live case presentation should be discussed in the original IDE 
application. 
The following information should be included when requesting approval for a live case 
presentation either when the original IDE application is submitted, or as a supplement to an 
IDE application: 
  The total number of live case presentations anticipated over the duration of the 
study; 
  A justification for the live case presentation; if more than one live case 
presentation is requested, provide a justification as to why more than one is 
necessary; 
  The name(s), date(s), and location(s) of the event (if known) where the live case 
presentation will be broadcast and the investigational site where the procedure 
will be conducted; 
  The name and qualifications of the operator/investigator performing the 
procedure, or reference to where the information is located if previously 
submitted or summarized in a different section of the IDE; 
  A copy of the informed consent document(s) for the live case presentation to be 
used at each investigational site; 
  A discussion of methods utilized to minimize risks; and 
  A discussion of how the live nature of the case will affect the scientific soundness 
of the study and how the live case data will be addressed in the statistical analysis 
or otherwise be used to support device approval or clearance. 
If it is not anticipated at the time of the original IDE, the live case presentation request should 
be submitted as a supplement to the original IDE in accordance with 21 CFR 812.35(a) at 
least 30 days prior to the planned presentation. This is because original IDE applications and 
supplements have a 30-day review period. The supplement may reference any information 
that was already included and approved in the original IDE. 
If a live case presentation is anticipated at the time of the original IDE application, but 
specifics about the live case presentation are not known at that time, FDA intends to focus its 
review on the risk analysis, the informed consent, and the impact of live case presentations 
on the study design and data analysis. 
7 Contains Nonbinding Recommendations 
FDA also has concerns related to clinical study execution as identified below. FDA therefore 
recommends that the following additional items be specifically addressed when designing or 
revising an investigational plan to include live case presentations: 
  Live case presentations typically include prior subject selection and may result in 
unblinding the investigator and subject. The potential for investigator and 
selection bias should be addressed, as well as how this bias will be minimized; 
  Sponsors should include a discussion of how subjects participating in live case 
presentations will be addressed in the planned endpoint analyses. For example, 
sponsors should specify if these subjects will be excluded from the overall 
effectiveness analysis and reported as a separate cohort. Sponsors should adjust 
sample sizes after considering whether subjects should be excluded from primary 
outcomes analyses; 
  Since a live case presentation presumably means that a subject is receiving the 
investigational treatment, the IDE protocol for treatment assignment may be 
violated if there is a randomization schedule. The sponsor should address any 
impact of the live case presentation on the protocols randomization schedule and 
how those changes, if any, could impact the study analysis; 
  Live case presentations should not cause any significant changes to the 
investigational protocol, other than potentially altering treatment assignment if the 
trial is randomized. The sponsor should describe in detail and justify any 
anticipated changes to the protocol, including subject follow-up and evaluation; 
  Data for subjects participating in live case presentations should be collected in 
accordance with the approved investigational plan and reported to FDA. FDA 
intends to review the data from the live case presentation for safety and 
effectiveness, whether the data are used in the statistical analysis or otherwise 
used to support a marketing submission. Live case presentations should be 
separately reported and also compared to the remaining investigational cohort in 
progress and final study reports as well as in any marketing submission; 
  If an unanticipated adverse device effect (UADE) requiring investigation and 
reporting to the Agency and all reviewing IRBs (21 CFR 812.150) occurs during a 
live case presentation, it should be noted in the UADE report that it took place 
during a live case presentation with a discussion of how the nature of the live case 
presentation may have impacted the adverse event; and 
  A risk analysis that includes a discussion of the potential increased risks to the 
subject posed by the live case presentation (21 CFR 812.25(c)). 
The live case presentation should be conducted only at an investigational site by an 
investigator who has signed an agreement with the sponsor pursuant to 21 CFR 812.43(c) 
and is currently participating in the study under an approved IDE. Sponsors must not use live 
case presentations to promote or test market an investigational device or to represent that the 
investigational device is safe or effective for the purposes for which it is being investigated 
(21 CFR 812.7(a) and (d)). 
As described above, live case presentations are often intended to recruit investigators and 
subjects to increase the likelihood of completing the investigation and are not integral to 
8 Contains Nonbinding Recommendations 
completion of the surgical or percutaneous procedure that is being broadcast or recorded. The 
Agency believes that the potential increased risks associated with live case presentations are 
not appropriate for use of an investigational device (i.e., one that has not been approved or 
cleared by FDA) under Expanded Access.7 In many cases, patients treated with an 
investigational device under Expanded Access would not meet the enrollment criteria for 
inclusion in a clinical investigation under an IDE or are otherwise unable to enroll in a 
clinical investigation (e.g., the clinical investigation has concluded or has reached enrollment 
capacity). The investigational device may present different or additional risks for these 
patients than for subjects enrolled in a clinical investigation under an IDE. 
V. Data Collection and Reporting 
The record-keeping requirements for investigators conducting an investigation that requires 
submission of an IDE application to FDA consists in part of maintaining records that include 
all relevant observations, including records concerning adverse device effects (whether 
anticipated or unanticipated) (21 CFR 812.140(a)(3)(ii)). There should be no less data 
collection for live case presentations than there is for the general investigational cohort. 
If an unanticipated adverse device effect occurs during a live case presentation, the 
investigator must report it to the sponsor and reviewing IRB as soon as possible, but in no 
event later than 10 working days after the investigator first learns of the effect (21 CFR 
812.150(a)(1)). The sponsor must immediately conduct an evaluation of the unanticipated 
adverse device effect (21 CFR 812.46(b)(1)) and report the results of the evaluation to FDA 
and all reviewing IRBs and participating investigators within 10 working days after the 
sponsor first receives notice of the effect (21 CFR 812.150(b)(1)). 
As mentioned above, live case presentations should not cause any significant changes to the 
investigational protocol. Generally, all per protocol follow-up appointments should be 
applicable to live case presentations. Information about the live case presentation should be 
provided in a progress report for the IDE at least annually, or as required by the approval 
requirements. The progress report required under 21 CFR 812.150(b)(5) should include the 
following information about the live case presentation: 
  Summary information: 
  Diagnostic indications for the procedure; 
  Description of all differences between the live case procedure and the 
investigational protocol; 
  Name(s) of the investigator(s) involved in the live case presentation and their 
role(s) in the case (e.g., surgeon, narrator, etc.); 
  Investigational site; 
  The IRB(s) and IRB chair(s) that approved the live case presentation; 
  The name of the event at which the live case presentation was broadcast, date 
of the live case presentation(s), and the date(s) of the broadcast (if different 
from the date of the live case presentation); and 
  Location of the event for live case presentation(s). 
                                                          
7 For more information about Expanded Access for investigational devices, see https://www.fda.gov/medical-
devices/device-advice-investigational-device-exemption-ide/expanded-access-medical-devices. 
9 Contains Nonbinding Recommendations 
  Subject-specific information: 
  The subjects identification codes for the particular study; 
  Subject demographics; 
  How the subject was selected, (e.g., fewest risk factors, prognosis); 
  Results and conclusions of the procedure, including a complete description of 
any adverse effects; and 
  Any other pertinent information relating to the safety of the device as used 
under conditions of the live case presentation (e.g., lot number, serial number, 
etc.). 
This information should be provided for any live case presentation that was attempted, even 
if it was aborted for any reason. In addition, if a specific live case presentation was approved 
but not performed, this should be submitted to FDA in the annual report, including the reason 
why it was not performed (e.g., lack of suitable subject for meeting date, business reasons). 
Because the information supporting approval of a live case presentation may vary, prior 
approval may be needed to conduct each live case presentation, even if one was granted 
previously. Sponsors are encouraged to consult with the FDA review Division in a pre-
submission to discuss their plans for live case presentations before submitting an IDE 
application or supplement to an IDE application. 
Also, as described above, summary information of those subjects who participate in live case 
presentations should be collected and reported in a separate section in the sponsors annual 
progress reports, in the final study report to the reviewing IRB and FDA, and in any future 
marketing submission(s). Clinical outcomes should be analyzed separately and summarized 
descriptively, unless a statistically valid comparison can be made with the rest of the study 
cohort. 
VI.  Conclusion 
This guidance provides recommendations as to the type of information that FDA believes 
will be useful in reviewing IDE applications containing a request for a live case presentation. 
By proactively anticipating live case presentations and prospectively identifying the study 
parameters around such live case presentations, the Agency believes that protections to 
human research subjects will be improved, burdens to the sponsor and the Agency will be 
minimized, and study validity related to live case presentations using investigational devices 
will be assured. 
10 Contains Nonbinding Recommendations 
Attachment A. Suggested elements of a request to include 
live case presentations 
The following is a list of recommended items to include, as applicable, in an original IDE 
application or a supplement to an IDE application when requesting live case presentations for 
clinical investigations of significant risk devices. 
General Information 
The sponsor should provide: 
  A detailed rationale for why the live case presentation is being requested, 
including an explanation of the status of subject enrollment and investigator 
recruitment; 
  The name, date, and location of the event (if known) where the live case 
presentation will be broadcast and investigational site where the procedure will be 
conducted; 
  A discussion of how the live case nature of the procedure will affect the scientific 
soundness of the study or necessitate any revisions of the protocol and planned 
statistical analysis; 
  Justification for the requested number of live case presentations; 
  Criteria for how potential subjects will be selected; 
  The potential effects of subject selection for live case presentations on unmasking 
investigator and subject; 
  Treatment assignment and the effect on the randomization schedule; 
  Information about the potential for selection bias and how this will be minimized; 
  Justification for study sample size. As live case presentation subjects may be 
excluded from the primary study analyses, the requested number of subjects may 
need to be adjusted to account for live case presentation(s); 
  A revised risk analysis that includes a discussion of the increased risks posed by 
the live case presentation; and 
  A statement that the live case presentations are being conducted at previously 
approved investigational sites by investigators who have signed an agreement 
with the sponsor pursuant to 21 CFR 812.43(c) and who are currently 
participating in the study. 
Informed Consent 
The sponsor should provide an informed consent document that complies with 21 CFR part 
50. The informed consent for a live case presentation should describe, where applicable: 
  Whether the procedure will be recorded for future viewing and/or broadcast to an 
audience during the conduct of the procedure; 
  That there is no additional direct benefit to the subject for participating in the live 
case presentation beyond the benefits of the clinical investigation, if any; 
  That it is not known whether participating in a live case presentation will affect 
clinical outcome compared to subjects who do not participate; 
  Any additional or increased risks posed by performing the procedure as a live 
case presentation, such as risks posed by increased anesthesia and/or procedure 
11 Contains Nonbinding Recommendations 
time, compared to the procedure not being performed as a live case presentation 
(see previous discussion under Risk Analysis); 
  Any additional or increased risks related to subject confidentiality that may occur 
as a result of participation in the live case presentation, such as privacy concerns 
related to the live case broadcast, and subsequent distribution and/or use of a 
video or other type of stored media of the procedure; and 
  Whether additional follow-up and evaluation may be warranted as a result of the 
subjects participation in a live case presentation and how such follow-up and 
evaluation may be different compared to the procedure not being performed as a 
live case presentation. 
If live case presentations involve children, assurance of the following additional safeguards 
for the protection of the rights, safety, and welfare of the children should be included in the 
request: 
  The added risks of being involved in a live case presentation will involve no more 
than minimal risk to the enrolled child; 
  Permission of the parent or guardians will be obtained as set forth in 21 CFR 
50.55; and 
  Adequate provisions will be made for soliciting the assent of the child as set forth 
in 21 CFR 50.55. 
Reporting and Analysis Plans 
The sponsor should provide: 
  A detailed description of proposed data collection and reporting for subjects 
participating in a live case presentation. Sponsors should address whether data 
collection and reporting will be according to the IDE protocol, and if not, provide 
a detailed description of (and justification for) any anticipated changes to the 
protocol. Subject follow-up and evaluation should be specifically discussed, and 
should be the same as that specified in the IDE protocol, unless the patients 
condition warrants additional follow-up and evaluation; and 
  An analysis plan for the live case presentations that include all relevant 
observations, including adverse device effects (whether anticipated or 
unanticipated), and specifying how the live case presentation data will be 
stratified and included in safety and/or efficacy analyses. 
Information Concerning IRB Review 
The sponsor of an investigation should provide: 
  A statement that it will obtain IRB approval before adding a live case presentation 
to the clinical study; and 
  A statement that the clinical outcomes of subjects treated in live case 
presentations will be included and analyzed with those of the other study subjects 
according to the pre-specified statistical analysis plan, as well as, analyzed and 
reported separately when included in reports to the FDA and as required by the 
IRB. 
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