Information Sheet Guidance 
For IRBs, Clinical Investigators, 
and Sponsors 
Frequently Asked Questions About 
Medical Devices 
Additional copies are available from: 
 
Office of Good Clinical Practice 
Office of Special Medical Programs, Office of the Commissioner 
Food and Drug Administration 
10903 New Hampshire Ave., WO32-5129 
Silver Spring, MD 20993-5129 
(Tel) (301)-796-8340 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf  
 
or 
 
Division of Small Manufacturers, International, and Consumer Assistance 
Office of Communication, Education and Radiation Programs 
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Ave., WO66-4521 
Silver Spring, MD 20993 
Tel: 1-800-638-2041 or 301-796-7100 
dsmica@fda.hhs.gov 
 
or 
 
Office of Communication, Training and Manufacturers Assistance, (HFM-40) 
Center for Biologics Evaluation and Research 
Food and Drug Administration 
1401 Rockville Pike 
Rockville, MD 20852 
Tel: 1-800-835-4709 or 301-827-1800 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health (CDRH) 
Center for Biologics Evaluation and Research 
 
January 2006  TABLE OF CONTENTS 
 
I. INTRODUCTION .................................................................................................................1 
II.  FREQUENTLY ASKED QUESTIONS ABOUT MEDICAL DEVICES........................1  
1.  What is a medical device?.............................................................................................................2 
2.  How does FDA classify medical devices?.....................................................................................2 
3.  What are examples of medical devices?.......................................................................................3 
4.  What is a premarket notification (510(k)) submission?.............................................................3 
5.  What is a premarket approval (PMA) application?...................................................................3 
6.  Where can I find more information on 510(k)s and PMAs?......................................................3 
7.  What is a humanitarian use device (HUD)?................................................................................3 
8.  What is a humanitarian device exemption (HDE) application?................................................4 
9.  What are the responsibilities of the IRBs regarding HDEs?.....................................................4 
10.  Is informed consent required when treating/diagnosing a patient with a HUD?.....................5 
     11.  What statute and regulations apply to medcial device clinical investigations?........................6 
12.  What type of device studies do the IDE regulations (21 CFR Part 812) cover?.......................6 
A. Significan Risk Device Studies.........................................................................................................6 
B. Non-Significant Risk Device Studies................................................................................................7 
C. Exempt Studies.................................................................................................................................8
13.  Are exempt studies ( i.e., exempt from the IDE regulation) subject to the requirements for 
informed consent and IRB review and approval?...............................................................................9 
14.  Does FDA require IRB review and approval of off-label use of a legally marketed device?..9 
15.  Must an IRB review a study conducted ater submission of (510(k)) to FDA but prior to 
FDA's decision on the submission?.......................................................................................................9 
16.  What regulation describes custom device?....................................................................................9  
17. Does an IRB need to review custom use?......................................................................................10 
18. Can a physician use an unapproved device in an emergency?...................................................10 
19.  What if the situation is not an emergency?  Can a patient with a serious illness or condition 
have access to an investigational device outside a study?............................ ............................11 
 
  Contains Nonbinding Recommendations 
 
 
 
 
Information Sheet Guidance 
1
 For IRBs, Clinical Investigators, and Sponsors
Frequently Asked Questions About Medical Devices  
 
 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance. 
 
 
 
 
I. INTRODUCTION 
 
This guidance is intended to assist clinical investigators and institutional review boards (IRBs) 
by answering common questions FDA receives concerning medical devices.  This document 
supersedes Medical Devices, Frequently Asked Questions about IRB Review of Medical Devices, 
and Emergency Use of Unapproved Medical Devices (September 1998) Office of Health Affairs, 
Food and Drug Administration.  This document was revised to make it consistent with the 
Agencys good guidance practices regulations (21 CFR 10.115). 
 
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 guidances means that something is suggested or 
recommended, but not required. 
 
II. FREQUENTLY  ASKED QUESTIONS ABOUT MEDICAL DEVICES  
 
                                                 
1 This guidance document was developed by the Good Clinical Practice Program in coordination with the Agency 
Centers.  This guidance document does not address medical devices subject to licensure as a biological product. 
Please direct questions concerning those devices to the Center for Biologics Evaluation and Research. 
 
 
  1 Contains Nonbinding Recommendations 
 
 
 
 
1.  What is a medical device? 
 
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent, or other similar or related article, including any component, part, or accessory, which 
is 
  recognized in the official National Formulary, or the United States Pharmacopeia, or any 
supplement to them, 
  intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, 
treatment, or prevention of disease, in man or other animals, or 
  intended to affect the structure or any function of the body of man or other animals, and 
which does not achieve its primary intended purposes through chemical action within or on the 
body of man or other animals and which is not dependent upon being metabolized for the 
achievement of its primary intended purposes (21 U.S.C. 321(h)). 
 
2.  How does FDA classify medical devices? 
 
In accordance with the Federal Food, Drug, and Cosmetic Act, FDA places all medical devices 
into one of three regulatory classes based on the level of control necessary to ensure safety and 
effectiveness of the device.  Classification is risk based, that is, the risk the device poses to the 
patient and/or the user is a major factor in determining the class to which it is assigned.   
 
Devices in all three classes are subject to general controls which require, in part, that companies:  
(1) register their establishments and list the medical devices they market with FDA; (2) 
manufacture their devices in accordance with Good Manufacturing Practices; and (3) label their 
devices in accordance with labeling regulations.  
 
Class I devices are subject only to general controls. They typically present the lowest potential 
for harm and are simpler in design than Class II or Class III devices.  Examples of Class I 
devices include elastic bandages, examination gloves, and hand-held surgical instruments. 
 
Class II devices are those for which general controls alone are insufficient to provide a 
reasonable assurance of safety and effectiveness.  In addition to complying with general controls, 
Class II devices are also subject to special controls identified by the agency, which may include 
special labeling requirements, performance standards and postmarket surveillance.  Examples of 
Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.   
 
Class III devices generally are those for which insufficient information exists to determine that 
general or special controls are sufficient to provide a reasonable assurance of safety and 
effectiveness.  Examples of Class III devices include replacement heart valves, silicone gel-filled 
breast implants, and implanted cerebellar stimulators. 
 
  2 Contains Nonbinding Recommendations 
 
 
 
 
3.  What are examples of medical devices? 
 
Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular 
grafts, intraocular lenses, and orthopedic pins.  A longer list of examples of medical devices is in 
the FDA Information Sheet Guidance, Significant Risk vs. Non-Significant Risk Devices.  
 
Medical devices also include diagnostic products.  Examples of diagnostics include in vitro 
diagnostic reagents and test kits such as pregnancy test kits, and imaging systems such as 
magnetic resonance imaging (MRI).  
 
4.  What is a premarket notification (510(k)) submission? 
 
A premarket notification, or 510(k), is submitted to FDA before a manufacturer proposes to 
market a medical device.  If FDA agrees the new device is substantially equivalent to a legally 
marketed device for which premarket approval is not required, the manufacturer may market it 
immediately. FDA does not require clinical data in most 510(k)s.  However, if clinical data are 
necessary to demonstrate substantial equivalence, the clinical study must comply with the IDE, 
IRB, and human subject protection (informed consent and additional safeguards for children in 
research) regulations.   See section 520(g) of the act and 21 CFR Parts 812, 56 and 50. 
 
5.  What is a premarket approval (PMA) application? 
 
A premarket approval (PMA) application is the most stringent type of device marketing 
application for medical devices.  FDA approves a PMA if it determines that the application 
contains sufficient valid scientific evidence to provide reasonable assurance that the device is 
safe and effective for its intended use(s). 
 
6.  Where can I find more information about 510(k)s and PMAs? 
 
Additional information is available about these programs on the Center for Devices and 
Radiological Healths website at: www.fda.gov/cdrh/devadvice/. 
 
7.  What is a humanitarian use device (HUD)? 
 
An HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases 
or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per 
year.  The Office of Orphan Products Development (OOPD) determines if a device meets 
specific requirements, including scientific rationale and population prevalence, for designation as 
a HUD. 
  
  3 Contains Nonbinding Recommendations 
 
 
 
8.  What is a humanitarian device exemption (HDE) application? 
 
A Humanitarian Device Exemption (HDE) application is similar to a PMA, but because a HUD 
is exempt from the effectiveness requirements of a PMA, an HDE application is not required to 
contain the results of scientifically valid clinical investigations demonstrating that the device is 
effective for its intended purpose.  However, the HDE must contain sufficient information for 
FDA to determine that the probable benefit to health outweighs the risk of injury or illness, 
taking into account the probable risks and benefits of currently available devices or alternative 
forms of treatment. Section 520(m)(2)(C).  An approved HDE authorizes marketing of an HUD.  
 
Under the statute, once the HDE is approved, the HDE holder is responsible for ensuring that the 
approved HUD is only administered at institutions that have an IRB constituted and acting 
pursuant to 21 CFR 56, including conducting continuing review of the use of the HUD.  In 
addition, an HUD should be administered only if such use has been approved by the Institutional 
Review Board (IRB) located at the facility, or by a similarly constituted IRB that has agreed to 
oversee such use and to which the local IRB has deferred in a letter to the HDE holder.   An 
HDE holder may wish to ensure that this happens by not shipping the HUD to the facility until it 
has received confirmation of IRB approval. 
 
NOTE:  HUDs should not be used until AFTER the HDE applicant obtains approval of the HDE 
from FDA and the IRB approves its use.  IRBs should ensure that HDE approval has been 
granted before approving the device for use at their institution.   
 
9.  What are the responsibilities of the IRBs regarding HDEs? 
 
Initial review: 
Initial IRB approval should be performed at a convened IRB meeting.  The IRB does not need to 
review and approve individual uses of an HUD, but rather the IRB may approve use of the 
device as it sees fit.  That is, the IRB may approve use of the HUD without any further 
restrictions, under a protocol, or on a case-by-case basis.  
 
Continuing review: 
IRBs may approve the use of the device for a period of time, not to exceed one year.  21 CFR 
56.109(f).  In some higher risk cases, IRBs have approved HUDs for a specific number of 
patients and have required a summary report before approving the use in additional patients.  
Continuing review should follow the requirements found at 21 CFR 56, and may be conducted 
using the expedited review procedures (see 21 CFR 56.110) unless the IRB determines that full 
board review should be performed.  The agency believes that the expedited review procedures 
are appropriate for continuing review since the initial review would have been performed by the 
full board and use of the HUD within its approved labeling does not constitute research.   
 
 
  4 Contains Nonbinding Recommendations 
 
 
 
10. Is informed consent required when treating/diagnosing a patient with an HUD? 
 
The act and the HDE regulations do not require informed consent.  Because an HDE provides for 
marketing approval, use of the HUD does not constitute research or an investigation which 
would normally require consent from the study subjects.  However, there is nothing in the law or 
regulations that prohibits a state or institution from requiring prospective informed consent, 
when feasible.  In fact, most HDE holders have developed patient labeling that incorporates 
information that may be used to assist a patient in making an informed decision about the use of 
the device.  For example, the patient labeling may contain a discussion of the potential risks and 
benefits of the HUD, as well as any procedures associated with the use of the device.  The HUD 
labeling also states that the device is a humanitarian use device for which effectiveness for the 
labeled indication has not been demonstrated.  See 21 CFR 814.104(b)(4)(ii). 
  
Unless it is an emergency, before an HUD is used off-label, the agency recommends that the 
HDE holder obtain FDA approval of the use following the compassionate use policy for 
unapproved devices.  (See Chapter III Expanded Access to Unapproved Devices of the IDE 
Policies and Procedures Guidance.2)  If FDA approves the compassionate use request, the 
physician should ensure that the patient protection measures are addressed before the device is 
used and should devise an appropriate schedule for monitoring the patient.  If the situation is life-
threatening and there is not time to get FDA approval for the off-label use, FDA recommends 
that the emergency use procedures outlined in the above referenced guidance be followed.  
 
Sometimes a physician or HDE holder may develop a research protocol designed to collect 
safety and effectiveness data to support a PMA for the device.  In that case, an IDE is not needed 
if the research is within the approved labeling; however, IRB approval for the investigational 
study must be obtained before the research may begin.  Informed consent must also be obtained 
from the subjects participating in the study.  If the research is for a new use, the IDE regulation 
must be followed.  21 CFR Parts 812, 50, and 56. 
 
11.  What statute and regulations apply to medical device clinical investigations? 
 
In accordance with section 520(g) and the regulations, clinical studies of medical devices must 
comply with FDAs human subject protection requirements (informed consent and additional 
safeguards for children in research) (21 CFR Part 50), Institutional Review Board (IRB) 
requirements (21 CFR Part 56), Investigational Device Exemptions (IDE) requirements (21 CFR 
Part 812), Financial Disclosure for Clinical Investigators requirements (21 CFR Part 54) 
regulations, as well as any other applicable regulations, including pertinent regulations at 21 
CFR Part 809 (In Vitro Diagnostic Devices For Human Use).   
 
12.  What types of device studies do the IDE regulations (21 CFR Part 812) cover? 
                                                 
2 This guidance may be found at www.fda.gov/cdrh/ode/idepolcy.html 
  5 Contains Nonbinding Recommendations 
 
 
 
 
There are three types of studies described in the regulations at 21 CFR Part 812:  significant risk 
(SR) device studies, non-significant risk (NSR) device studies, and exempt studies.  A brief 
description of these types of studies follows.  Please refer to the FDA Information Sheet 
Guidance Significant Risk and Nonsignificant Risk Medical Device Studies for more detailed 
information about SR and NSR device studies, the importance of the IRBs review, the 
regulatory requirements for these studies, and examples of devices in each category.    
 
A. Significan t Risk Device Studies 
 
A significant risk device means an investigational device that: 
  Is intended as an implant and presents a potential for serious risk to the health, safety, or 
welfare of a subject; 
  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; 
  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 
  Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 
(21 CFR 812.3(m)) 
 
Sponsors of investigational SR device studies are required to get an approved IDE from FDA 
before starting their study.  21 CFR 812.20  (FDA gives each IDE a number - for example 
#GXX0000, where XX denotes the year of the submission).  Sponsors and clinical investigators 
of these studies must comply with the regulations at 21 CFR Part 812, "Investigational Device 
Exemptions." 
 
If FDA disapproves an IDE, FDAs letter will describe the reasons for the disapproval.  If the 
sponsor submits an IDE amendment satisfactorily addressing the issues in FDAs letter, the 
agency sends an IDE approval letter to the sponsor.  In accordance with the regulations at Part 
812, the study may not start until both FDA and the IRB have given their approval.  
 
Note:  A conditional approval letter from FDA allows the study to begin if the study is approved 
by the IRB, but requires the sponsor to provide additional clarifying information in order to 
obtain full approval for the study. 
 
IRBs do not have to make the SR or NSR determination if FDA has already made the risk 
determination.  Most often, clinical investigators submit SR device investigations for IRB review 
after the study has already received IDE approval from FDA.  IRBs may ensure that SR device 
investigations have an FDA-approved IDE by asking the clinical investigator to request from the 
sponsor a copy of FDAs IDE approval letter.   
 
  6 Contains Nonbinding Recommendations 
  
  
  
An IRB may be asked to review an SR device study before the sponsor receives FDA approval 
of an IDE submission.  Under this circumstance, IRBs should be aware that because it is possible 
that FDA may not approve the IDE or may request significant changes to the research protocol, 
the IRB may need to re-evaluate the study after FDA reviews the application.  If an IRB 
approves the significant risk device study before FDA approves the IDE, there may be more of a 
risk that clinical investigators will mistakenly enroll subjects before the study should be started 
(i.e, before FDA approves the IDE.)  
  
  
B.  Non-Significant Risk Device Studies 
  
An NSR device is an investigational device that does not meet the definition of a significant risk 
device.  If an IRB finds that an investigational medical device study poses a NSR, the sponsor 
does not need to submit an IDE to FDA before starting the study.  If the IRB determines that the 
proposed study is an NSR study, the IRB may proceed to review the study under 21 CFR 56.109 
and 21 CFR 56.111.  FDA considers an NSR device study to have an approved IDE after IRB 
approval and when sponsors meet the abbreviated requirements at 21 CFR 812.2(b).  
Consequently, in most cases, FDA is not aware of non-significant risk device studies.      
  
As stated above, if FDA has already made the risk determination, the IRB does not need to 
duplicate this effort.  If, however, FDA has not made the risk determination or the IRB disagrees 
with the NSR determination made by a sponsor, then the IRB must notify the investigator and, 
where appropriate, the sponsor, that the study involves a significant risk device (21 CFR 812.66).  
If a sponsor or an IRB needs help in making the SR/NSR determination, it may ask for a written 
determination from FDA.3   
  
The IRB should consider the following in determining whether a device study poses a SR or 
NSR: 
  the sponsors description of why the study is not SR 
  whether the proposed NSR research study meets the definition of  significant risk (see 
above) 
  the proposed use of the device as well as any protocol related procedures and tests, not 
just the device (test article) alone. (This process is different from the IRB review process 
found at 21 CFR 56.111(a)(2)).) 
  additional information from the sponsor, if needed. 
  
  
  
                                                  
3 See the guidance memorandum entitled, Procedures for Handling Inquiries Regarding the Need for an 
Investigational Device Exemptions Application for Research Involving Medical Devices at 
www.fda.gov/cdrh/ode/blue-ide-d01-1.html  
  7  Contains Nonbinding Recommendations 
 
 
 
C. Exempt  Studies 
 
In accordance with 21 CFR 812.2(b), sponsors and investigators of certain studies are exempt 
from the requirements of 21 CFR Part 812, with the exception of 812.119 (disqualification of a 
clinical investigator).   Examples of exempt studies are consumer preference testing, testing of a 
device modification, or testing of two or more devices in commercial distribution if the testing 
does not collect safety or effectiveness data, or put subjects at risk.4
 
Studies of an already cleared medical device in which the device is used or investigated in 
accordance with the indications in the cleared labeling are exempt from Part 812.5  Note:  Studies 
of a cleared device for a new use must comply with the human subject protection (informed 
consent and additional safeguards for children in research), IRB, and IDE regulations.  Similarly, 
studies of a PMA approved device are exempt from the IDE requirements if the device is being 
studied for the indications in the approved labeling. 
 
In addition, diagnostic device studies (e.g., in vitro diagnostic studies) are exempt from the 
requirements of 21 CFR Part 812 under certain circumstances.  The study is exempt as long as 
the sponsor complies with the requirements at 21 CFR 809.10(c) for labeling, and if the testing: 
(i) is noninvasive; (ii) does not require an invasive sampling procedure that presents significant 
risk; (iii) does not by design or intention introduce energy into a subject; and (iv) is not used as a 
diagnostic procedure without confirmation of the diagnosis by another, medically established 
diagnostic product or procedure.  21 CFR 812.2(c)(3). 
 
13.  Are IDE exempt studies subject to the requirements for informed consent and IRB 
review and approval under Parts 50 and 56? 
 
If an exempt study is being conducted to collect data to support either a clinical investigation or a 
marketing application, then the study must comply with 21 CFR Part 50 and should comply with 
21 CFR Part 56.  21 CFR 50.1(a), 21 CFR 50.20, 21 CFR 56.101(a), 21 CFR 56.103. 
 
14.  Does FDA require IRB review and approval of off-label use of a legally marketed 
device? 
  
No, when a physician uses a legally marketed device outside its labeling to treat a patient and no 
research is being done, IRB review is not required.  Note: Although not required by FDA, an 
IRB may still decide on its own initiative to review such use.  Yes, when the off-label use of a 
legally marketed device is part of a research study collecting safety and effectiveness data 
involving human subjects, IRB review and approval is required (21 CFR 812.2(a)). 
 
                                                 
4 See 21 CFR 812.2(c)(4). 
5 See 21 CFR 812.2(c)(1) and (2). 
  8 Contains Nonbinding Recommendations 
 
 
 
For additional information on the off-label use of devices, see the FDA Information Sheet 
guidance,  Off-label and Investigational Use of Marketed Drugs, Biologics and Medical 
Devices.6
 
15.  Must an IRB review a study conducted after submission of a (510(k)) to FDA but prior 
to FDAs decision on that submission? 
 
Yes.  During FDAs review of the premarket notification submission, the device remains an 
investigational product.  Therefore, the human subject protection (informed consent and 
additional safeguards for children in research), IRB, and IDE regulations apply.  The device may 
not be distributed, except for investigational use, unless FDA clears the device for marketing. 
 
16.  Can a physician use an unapproved device in an emergency? 
 
In general, an unapproved medical device may be used only on human subjects when the device 
is under clinical investigation and when used by investigators participating in a clinical trial.  
Section 561 of the Act, however, recognizes that there may be circumstances under which a 
health care provider may wish to use an unapproved device to save the life of a patient or to 
prevent irreversible morbidity when there exists no other alternative therapy.  For investigational 
devices under an IDE, the IDE regulation permits deviations from the investigational plan 
without prior approval when necessary to protect the life or physical well-being of a subject in an 
emergency. (See 21 CFR 812.35(a)).  A physician may treat a patient with an unapproved 
medical device in an emergency situation if he/she concludes that:  
  The patient has a life-threatening condition that needs immediate treatment;7  
  No generally acceptable alternative treatment for the condition exists; and  
  Because of the immediate need to use the device, there is no time to use existing 
procedures to get FDA approval for the use.  
FDA expects the physician to make the determination that the patient's circumstances meet the 
above criteria, to assess the potential for benefit from the use of the unapproved device, and to 
have substantial reason to believe that benefits will exist.  In the event that a device is used in 
circumstances meeting the criteria listed above, the physician should follow as many of the 
patient protection procedures listed below as possible: 
  Informed consent from the patient or a legal representative;  
  Clearance from the institution as specified by their policies;  
                                                 
6 This guidance can be found at: www.fda.gov/oc/ohrt/irbs/offlabel.html 
7 FDA considers life-threatening condition to include serious diseases or conditions such as sight-threatening and 
limb-threatening conditions as well as other situations involving risk of irreversible morbidity. 
  9 Contains Nonbinding Recommendations 
 
 
 
  Concurrence of the IRB chairperson;  
  An assessment from a physician who is not participating in the study; and  
  Authorization from the IDE sponsor, if an IDE exists for the device.  
 
While prior approval for shipment or emergency use of the investigational device is not required, 
the use must be reported to FDA by the IDE sponsor within 5 working days from the time the 
sponsor learns of the use. 21 CFR 812.35(a)(2) and 812.150(a)(4).  The report should contain a 
summary of the conditions constituting the emergency, patient outcome information, and the 
patient protection measures that were followed.  If no IDE exists, the physician should follow the 
above procedures and report the emergency use to CDRH or CBER.    
 
For additional information on the procedures physicians and IRBs should follow in an 
emergency use situation, please see Chapter III Expanded Access to Unapproved Devices of the 
guidance entitled, IDE Policies and Procedures.8   
 
17.  What if the situation is not an emergency?  Can a patient with a serious illness or 
condition have access to an investigational device outside a study?  
 
Yes, FDA recognizes that there are circumstances in which an investigational device is the only 
option available for a patient faced with a serious or life-threatening condition (hereinafter 
referred to as "compassionate use").  Unlike emergency use of an unapproved device discussed 
above, prior FDA approval is needed before compassionate use occurs.  Section 561(b) of the act 
and 21 CFR 812.35.   In order to obtain agency approval, the sponsor should submit an IDE 
supplement requesting approval for a protocol deviation under section 812.35(a) in order to treat 
the patient. The IDE supplement should include: 
  A description of the patient's condition and the circumstances necessitating treatment;  
  A discussion of why alternatives therapies are unsatisfactory and why the probable 
risk of using the investigational device is no greater than the probable risk from the 
disease or condition;  
  An identification of any deviations in the approved clinical protocol that may be 
needed in order to treat the patient; and  
  The patient protection measures listed above that will be followed.  
                                                 
8 This guidance may be found at: www.fda.gov/cdrh/ode/idepolcy.html
 
  10 Contains Nonbinding Recommendations 
 
 
 
The patient identified in the supplement should not be treated with the device until FDA 
approves its use under the proposed circumstances.  In reviewing this type of request, FDA will 
consider the above information as well as whether the preliminary evidence of safety and 
effectiveness justifies such use and whether such use would interfere with the conduct of a 
clinical trial to support marketing approval. 
If the request is approved, the attending physician should devise an appropriate schedule for 
monitoring the patient, taking into consideration the investigational nature of the device and the 
specific needs of the patient.  The patient should be monitored to detect any possible problems 
arising from the use of the device.  Following the compassionate use of the device, a follow-up 
report should be submitted to FDA in which summary information regarding patient outcome is 
presented.  If any problems occurred as a result of device use, they should be discussed in the 
supplement and reported to the reviewing IRB as soon as possible. 
 
Additional information on the procedures physicians and IRBs should follow in compassionate 
use situations may be found in Chapter III Expanded Access to Unapproved Devices of the 
guidance entitled, IDE Policies and Procedures. 9
 
18.  What is the definition of a custom device? 
   
To be considered a custom device, the device must meet all of the following criteria, which are 
described in section 520(b) of the act and at 21 CFR 812.3(b):   
(1) It necessarily deviates from devices generally available or from an applicable 
performance standard or premarket approval requirement in order to comply with the 
order of an individual physician or dentist;  
(2) The device is not generally available to, or generally used by, other physicians or 
dentists; 
(3) It is not generally available in finished form for purchase or for dispensing upon 
prescription;  
(4) It is not offered for commercial distribution through labeling or advertising; and 
(5) It is intended for use by an individual patient named in the order form of a physician 
or dentist, and is to be made in a specific form for that patient, or is intended to meet the 
special needs of the physician or dentist in the course of professional practice (such as a 
particular operating tool).   
 
19.  Does an IRB need to review custom use? 
 
FDA regulations do not require review and approval for custom device use.  However, FDA 
recommends that as many of the patient protection measures listed in paragraph 16 be followed 
as possible.  IRBs should be familiar with the regulatory requirements for custom devices 
                                                 
9 This guidance may be found at: www.fda.gov/cdrh/ode/idepolcy.html
  11 Contains Nonbinding Recommendations 
 
 
 
because physicians or institutions may seek information from the IRB about the use of a custom 
device in patients at their healthcare facility.  IRBs may develop procedures for the use of 
custom devices to ensure that patient protection measures are thoughtfully carried out.    
 
  
  12