Frequently Asked Questions About Medical Devices


1 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 Progra ms, Office of the Commissioner Food and Drug Administration 10903 New Hampshire Ave., WO32-5129 Silver Spring, MD 20993-5129 (Tel) (301)-796-8340 nformation/Guidances/UCM127067.pdf or Division of Small Manufacturers, Inte rnational, and Consumer Assistance Office of Communication, Education and Radiation Programs Center for Devices an d 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 [email protected] 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 csBloodVaccines/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

2 TABLE OF CONTENTS 1 ... I. INTRODUCTION II. FREQUENTLY ASKED QUESTIONS ABOUT MEDICAL DEVICES ... 1 1. What is a medical device? ... ...2 ces?...2 2. How does FDA classi fy medical devi 3 3. What are examples of medical devices?... 4. What is a premarket notification (510(k)) submission? ...3 proval (PMA) application? ... 3 5. What is a premarket ap 3 Where can I find more informat ... ion on 510(k)s and PMAs? 6. 7. What is a humanitarian use device (HUD)?... ...3 8. What is a humanitarian device exemption (HDE) application?...4 ... ...4 9. What are the responsibilities of the IRBs regarding HDEs ? ... 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 ... 6 A. Significan Risk Device Studies B. 7 Non-Significant Risk Device Studies ... Exempt Studies ... ..8 C. IDE regulation) subject to the requirements for 13. Are exempt studies ( i.e., exempt from the nsent and IRB review and approval informed co ?...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 ... ...9 FDA's decision on the su bmission? m device?... ..9 16. What regulation de o scribes cust 17. Does an IRB need to review custom use?... .10 ...10 ce in an emergency? 18. Can a physician use an unapproved devi 19. What if the situation is not an emergency? Can a patient with a serious illness or condition an investigational device outside a study? ... ...11 have access t o

3 Contains Nonbinding Recommendations Information Sheet Guidance 1 For IRBs, Clinical Investigators, and Sponsors Frequently Asked Question s 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 pe rson and does not operate to bind FDA or the public. You can use an alternative approach if it satisfi es the requirements of the applicable statutes and regulations. If you want to discuss an alternativ e approach, contact the FDA staff responsible for the appropriate FDA staff, call the appropriate implementing this guidance. If you cannot identify number listed on the title page of this guidance. I. INTRODUCTION This guidance is intended to assist clinical i nvestigators and institutional review boards (IRBs) A receives c oncerning medical devices. This document by answering common questions FD Medical Devices , supersedes IRB Review of Medical Devices , Frequently Asked Questions about and Emergency Use of Unapproved Medical Devices (September 1998) Office of Health Affairs, s revised to make it consistent with the Food and Drug Administration. This document wa regulations (21 CFR 10.115). Agency’s good guidance practices FDA's guidance documents, including this guida nce, do not establish legally enforceable current thinki ng on a topic and should responsibilities. Instead, guidances describe th e Agency's be viewed only as recommendations, unless spec ific regulatory or stat utory requirements are cited. The use of the word in Agency guidances means that something is suggested or should recommended, but not required. T MEDICAL DEVICES ONS ABOU II. FREQUENTLY ASKED QUESTI 1 This guidance document was developed by the Good Clin ical 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

4 Contains Nonbinding Recommendations 1. What is a medical device? machine, contrivance, implant, in vitro A medical device is an instrument, apparatus, implement, reagent, or other similar or re ponent, part, or accessory, which lated article, including any com is— acopeia, or any • recognized in the official National Formulary, or the United States Pharm supplement to them, • o intended for use in the diagnosis of disease or ther conditions, or in the cure, mitigation, n or other animals, or e, in ma treatment, or prevention of diseas • intended to affect the structur e or any function of the body of man or other anim als, and which does not achieve its primary intended purpo ses through chemical action within or on the body of m an or other animals and which is no t dependent upon being metabolized for the achievement of its primary intende d purposes (21 U.S.C. 321(h)). 2. How does FDA classify medical devices? rdance with the Federal Food, Drug, and Cosmetic Act, FDA places all medical devices In acco ased on the le vel of control necessary to ensure safety and into one of three regulatory classes b based, that is, the risk the device poses to the effectiveness of the device. Classification is risk patient and/or the user is a major factor in determining the class to which it is assigned. anies: Devices in all three classes are su bject to general controls which re quire, in part, that comp e medical devices they market with FDA; (2) (1) register their establishments and list th ood Manufacturing Practices ; and (3) label their manufacture their devices in accordance with G devices in accordance with labeling regulations. resent the lowest potential Class I devices are subject only to general controls. They typically p 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. e a Class II devices are those for which general controls alone are insufficient to provid reasonable assurance of safety and effectiveness. In addition to complying with general controls, Class II devices are also subject to special cont rols 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. lly are those for which insufficient information exists to determine that Class III devices genera general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness. Examples of Class III devices incl ude replacement heart valves, silicone gel-filled breast implants, and implante d cerebellar stimulators. 2

5 Contains Nonbinding Recommendations 3. What are examples of medical devices? kers, vascular sutures, pacema Examples of medical devices incl ude surgical lasers, wheelchairs, grafts, intraocular lenses, and ort hopedic pins. A longer list of exam ples of medical devices is in the FDA Information Sheet Guidance, “Significa nt Risk vs. Non-Significant Risk Devices.” Medical devices also include diagnostic products . Examples of diagnostics include in vitro aging systems such as diagnostic reagents and test kits such as pregnancy test kits, and im magnetic resonance imaging (MRI). 4. What is a premarket noti fication (510(k)) submission? a manufacturer proposes to d to FDA before A premarket notification, or 510(k), is submitte market a medical device. If FDA agrees the new device is substantially e quivalent to a legally marketed device for which premarket approval is not required, the manuf acturer may market it immediately. FDA does not require c linical 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 of the act and 21 CFR Parts 812, 56 and 50. research) regulations. See section 520(g) 5. What is a premarket a pproval (PMA) application? arketing e most stringent type of device m A premarket approval (PMA) application is th application for medical devices. FDA approves a PMA if it determines that the application contains sufficient valid scientific evidence to provide reasonable assura nce that the device is safe and effective for its intended use(s). ion about 510(k)s and PMAs? 6. Where can I find more informat ese programs on the Center for Devices and Additional information is available about th Radiological Health’s website at: /. 7. What is a humanitarian use device (HUD)? An HUD is a device that is intended to benefit pa tients in the treatment and diagnosis of diseases anifested in fewer than 4,000 individuals in the United States per or conditions that affect or is m year. The Office of Orphan Products Development (OOPD) determines if a device meets specific requirements, including scientific ration ale and population prevalence, for designation as a HUD. 3

6 Contains Nonbinding Recommendations 8. What is a humanitarian devi ce exemption (HDE) application? A Humanitarian Device Exemption (HDE) application is similar to a PMA, but because a HUD the effectiveness requirements of a PMA, an HDE applica tion is not required to is exempt from contain the results of scientifically valid clinical investigations demonstr ating that the device is effective for its intended purpose. However, th e HDE must contain sufficient information for FDA to determine that the probable benefit to health outweighs the risk of injury or illness, ailable devices or alternative taking into account the probable ri sks and benefits of currently av pproved HDE authorizes marketing of an HUD. forms of treatment. Section 520(m)(2)(C). An a Under the statute, once the HDE is approved, the HDE holder is responsible for ensuring that the inistered at institutions that have an IRB constituted and acting approved HUD is only ad m pursuant to 21 CFR 56, including conducting continuing review of the use of the HUD. In addition, an HUD should be administ ered 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 s by not shipping the HUD to the facility until it HDE holder may wish to ensure that this happen has received confirmation of IRB approval. NOTE: HUDs should not be used until AFTER th e HDE applican t obtains approval of the HDE FDA and the IRB approves its use. IRBs should ensure that HDE approval has been from granted before approving the device for use at their institution. 9. What are the responsibilities of the IRBs regarding HDEs? Initial review: eting. The IRB does not need to Initial IRB approval should be performed at a convened IRB me 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 ma y approve use of the HUD without any further restrictions, under a protocol, or on a case-by-case basis. Continuing review: od of time, not to exceed one year. 21 CFR IRBs may approve the use of the device for a peri e higher risk cases, IRBs have approved HUDs for a specific number of 56.109(f). In som patients and have required a summary report befo re approving the use in additional patients. Continuing review should follow the requireme nts found at 21 CFR 56, and may be conducted using the expedited review pr ocedures (see 21 CFR 56.110) unless the IRB determines that full board review should be performed. The agency believes that the exped ited review procedures are appropriate for continuing revi ew since the initial review w ould have been performed by the d labeling does not constitute research. full board and use of the HUD within its approve 4

7 Contains Nonbinding Recommendations 10. Is informed consent required w hen treating/diagnosing a patient with an HUD? The act and the HDE regulations do not require informed consent. Because an HDE provides for rketing approval, use of the HUD does not co nstitute research or an investigation which ma would normally require consent from the study subjects. However, there is nothing in the law or regulations that prohibits a state or instituti on from requiring prospective informed consent, when feasible. In fact, most HDE holders have developed patient labe ling that incorporates t in making an informed decision about the use of information that may be used to assist a patien the device. For example, the patient labeling ma the potential risks and y contain a discussion of 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 demons trated. 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 U napproved Devices of the “IDE 2 Policies and Procedures Guidance.” ) If FDA approves the compassionate use request, the addressed before the device is physician should ensure that the patient protection measures are used and should devise an appropria te 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 devel op a research protocol designed to collect support a PMA for the device. In that case, an IDE is not needed fectiveness data to safety and ef if the research is within the approved labeli ng; however, IRB approval for the investigational study must be obtained before the research may be gin. Informed consent must also be obtained from the subjects participating in th e 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? dical devices must In accordance with section 520(g) and the regulati ons, clinical studies of me comply with FDA’s human subject protection requirements (informed consent and additional safeguards for children in research) (21 CF R 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 othe r applicable regulations, includ ing pertinent regulations at 21 CFR Part 809 (In Vitro Diagnosti c Devices For Human Use). 812) cover? 12. What types of device studies do the IDE regulations (21 CFR Part 2 This guidance may be found at 5

8 Contains Nonbinding Recommendations nificant risk There are three types of studies described in the regulations at 21 CFR Part 812: sig (SR) device studies, non-signifi cant 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 Ri sk Medical Device Studies” for more detailed information about SR and NSR device studies, the importance of the IRB’s review, the regulatory requirements for these studies, and examples of devices in each category. A. Significan t Ri sk Device Studies ational device that: A significant risk device means an investig • Is intended as an implant and presents a potentia l for serious risk to the health, safety, or welfare of a subject; • Is purported or represented to be for a use in supporting or su staining hum an life and presents a potential for serious risk to the he alth, safety, or welfare of a subject; • Is for a use of substantial importance in dia gnos ing, curing, mitigating, or treating disease, or and presents a potential for serious risk to otherwise preventing impairment of human health 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 ple before starting their study. 21 CFR 812.20 (FDA gives each IDE a number - for exam linical investigators #GXX0000, where XX denotes the year of the submission). Sponsors and c with the regulations at 21 CFR Part 812, "Investigational Device of these studies must comply Exemptions." If FDA disapproves an IDE, FDA’s letter will desc ribe the reasons for the disapproval. If the endment satisfactorily addressing the issues in FDA’s letter, the sponsor submits an IDE am agency sends an IDE approval lett er to the sponsor. In accordan ce with the regulations at Part 812, the study may not start unt il both FDA and the IRB have given their approval. udy to begin if the study is approved Note: A conditional approval letter from FDA allo ws the st by the IRB, but requires the sponsor to provide additional clarifying in formation in order to obtain full approval for the study. de the risk IRBs do not have to make the SR or NSR determination if FDA has already ma determination. Most often, clinical investigator s submit SR device investigations for IRB review after the study has already receiv ed IDE approval from FDA. IRBs may ensure that SR device the clinical investigator to request from the investigations have an FDA-approved IDE by asking sponsor a copy of FDA’s IDE approval letter. 6

9 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 ificant changes to the research protocol, that FDA may not approve the IDE or may request sign r FDA reviews the application. If an IRB the IRB may need to re-evaluate the study afte approves the significant risk device study before F DA approves the IDE, there may be more of a risk that clinical inve stigators will mistakenly enroll subjects before th e 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 do es not meet the definition of a significant risk device. If an IRB finds that an investigational medical device study poses a NSR, the sponsor nes that the i does not need to submit an IDE to FDA before starting the study. If the IRB determ proposed study is an NSR study, the IRB may pr oceed 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 abbr eviated requirements at 21 CFR 812.2(b). Consequently, in most cases, FDA is not aware of non-significant risk devi ce studies. risk determination, the IRB does not need to As stated above, if FDA has already made the de the risk determination or the IR duplicate this effort. If, however, FDA has not ma B disagrees ination made by a sponsor, th en the IRB must notify the investigator and, with the NSR determ cant risk device (21 CFR 812.66). where appropriate, the sponsor, that the study involves a signifi If a sponsor or an IRB needs he ation, it may ask for a written lp in making the SR/NSR determin 3 determination from FDA. The IRB should consider the following in dete rmining whether a device study poses a SR or NSR: • the sponsor’s description of why the study is not SR • whether the proposed NSR research study meets the definition of “s ignificant risk” (see above) • the proposed use of the device as well as any protocol related proce dures and tests, not just the device (test article) alone. (This proc ess is different from th e IRB review process found at 21 CFR 56.111(a)(2)).) • additional information from the sponsor, if needed. 3 d, “Procedures for Handling Inquir See the guidance memorandum entitle ies Regarding the Need for an for Research Involving Medical Devices” at Investigational Device Exemptions Application 7

10 Contains Nonbinding Recommendations C. Exempt Studies In accordance with 21 CFR 812.2(b), sponsors and investigators of certain studies are exempt the requirements of 21 CFR Part 812, with the exception of §812.119 (disqualification of a from clinical investigator). Exampl es of exempt studies are consumer preference testing, testing of a device modification, or testing of two or more de vices in commercial dist ribution if the testing 4 does not collect safety or effectiven ess data, or put subjects at risk. Studies of an already cleared medical device in which the device is used or investigated in 5 Note: Studies accordance with the indication s in the cl eared labeling are exempt from Part 812. of a cleared device must comply with the human subject protection (informed for a new use consent and additional safeguards for children in re search), 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. tro diagnostic studies) are exempt from the In addition, diagnostic device studies (e.g., in vi requirements of 21 CFR Part 812 und er certain circumstances. The study is exempt as long as and if the testing: CFR 809.10(c) for labeling, the sponsor complies with the requirements at 21 (i) is noninvasive; (ii) does not require an invasive sampling pro cedure that presents significant sign or intention in troduce energy into a subject; a risk; (iii) does not by de nd (iv) is not used as a diagnostic procedure without confirmation of th e 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? pt study is being conducted to collect data to support either a clin ical investigation or a If an exem rketing application, then the study must comply with 21 CFR Part 50 and should comply with ma CFR 50.20, 21 CFR 5 21 CFR Part 56. 21 CFR 50.1(a), 21 6.101(a), 21 CFR 56.103. and approval of off-label use 14. Does FDA require IRB review of a legally marketed device? No, when a physician uses a legally marketed devi ce outside its labeling to treat a patient and no DA, an research is being done, IRB review is not required. Note: Although not required by F such use. Yes, when the off-label use of a IRB may still decide on its own initiative to review legally marketed device is part of a research study collecting safety and effectiveness data involving human subjects, IRB review a nd 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

11 Contains Nonbinding Recommendations devices, see the FDA Information Sheet For additional information on the off-label us e of guidance, “ ‘Off-label’ and I nvestigational Use of Marketed Drugs, Biologics and Medical 6 Devices.” 15. Must an IRB review a study conducted after submission of a (510(k)) to FDA but prior to FDA’s decision on that submission? ains an arket notification submission, the device rem Yes. During FDA’s review of the prem efore, the human subject protection (informed consent and investigational product. Ther B, and IDE regulations apply. The device may additional safeguards for children in research), IR not be distributed, except for i nvestigational use, unless FDA cl ears the device for marketing. 16. Can a physician use an unapproved device in an emergency? n subjects when the device used only on huma In general, an unapproved medical device may be is under clinical investig ation and when used by investigators pa rticipating in a clinical trial. Section 561 of the Act, however, recognizes th at there may be circumstances under which a health care provider may wish to use an unapproved device to save the lif e of a patient or to ive therapy. For investigational prevent irreversible morbidity wh en there exists no other alternat devices under an IDE, the IDE regulation permits deviations from the investigational plan e life or physical well-being of a subject in an without prior approval when necessary to protect th emergency. (See 21 CFR 812.35(a)). A physician may treat a patient with an unapproved ation if he/she concludes that: medical device in an emergency situ 7 has a life-threatening cond ition that needs immediate treatment; • The patient ent for the condition exists; and No generally acceptable alternative treat m • • Because of the imme diate need to use the device, there is no time to use existing procedures to get FDA approval for the use. stances meet the FDA expects the physician to make the determina tion that the patient's circum it from the use of the unapproved device, and to above criteria, to assess the potential for benef have substantial reason to believe that benefits will exist. In the event that a device is used in bove, the physician should follow as many of the circumstances meeting the criteria listed a patient protection procedures listed below as possible: • Informed consent from the patient or a legal representative; specified by their policies; • Clearance from the institution as 6 This guidance can be found at: ww 7 FDA considers “life-threatening condition” to include seri ous diseases or conditions such as sight-threatening and limb-threatening conditions as well as other situations involving risk of irreversible morbidity. 9

12 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. e of the investigational device is not required, ent or emergency us While prior approval for shipm the time the the use must be reported to FDA by the IDE spons or within 5 working days from sponsor learns of the use. 21 CFR 812.35(a)(2) and 812.150(a)(4). The re port should contain a summary of the conditions cons tituting the emergency, patient outcome information, and the If no IDE exists, the physician should follow the patient protection measures that were followed. above procedures and report the emer gency use to CDRH or CBER. physicians and IRBs should follow in an For additional information on the procedures II Expanded Access to Unapproved Devices of the ation, please see Chapter I emergency use situ 8 guidance entitled, “IDE Policies and Procedures.” th a serious illness or 17. What if the situation is not an emergenc y? Can a patient wi igational device outside a study? condition have access to an invest Yes, FDA recognizes that there are circumstances in which an investigational device is the only option ava ilable for a patient faced with a seri ous or life-threatening condition (hereinafter emergency use of an unapproved device discussed referred to as "compassionate use"). Unlike 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 devi ation under section 812.35(a) in order to treat the patient. The IDE supplement should include: s condition and the circumstances necessitating treatment; • A description of the patient' • ies are unsatisfactory and why the probable A discussion of why alternatives therap no greater than the pr obable risk from risk of using the investigational device is the disease or condition; y be An identification of any deviations in the otocol that ma approved clinical pr • needed in order to treat the patient; and d above that will be followed. protection measures liste • The patient 8 This guidance may be found at: 10

13 Contains Nonbinding Recommendations The patient identified in the supplement shoul d not be treated with the device until FDA ype of request, FDA will e proposed circumstances. In reviewing this t approves its use under th consider the above information as well as wh ether the preliminary ev idence of safety and effectiveness justifies such us e and whether such use would in terfere with the conduct of a clinical trial to suppor t marketing approval. an appropriate schedule for attending physician should devise If the request is approved, the tion the investigationa l nature of the device and the monitoring the patient, taking into considera specific needs of the patient. The patient shoul d 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 summ ary 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 revi ewing IRB as soon as possible. passionate Additional information on the procedures physicia ns and IRBs should follow in com xpanded Access to Unapproved Devices of the use situations may be found in Chapter III E 9 licies and Procedures.” guidance entitled, “IDE Po 18. What is the definiti on of a custom device? the following criteria, which are To be considered a custom device, the device mu st meet all of described in section 520(b) of the act and at 21 CFR 812.3(b): from an applicable nerally available or (1) It necessarily deviates from devices ge 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 fini shed form for purchase or for dispensing upon prescription; ribution through labeling or advertising; and ercial dist (4) It is not offered for comm d in the order form of a physician tient name (5) It is intended for use by an individual pa 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 th e 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 paragraph 16 be followed that as many of the patient protect ion measures listed in recommends e regulatory requirements for custom devices as possible. IRBs should be familiar with th 9 This guidance may be found at: 11

14 Contains Nonbinding Recommendations ation from the IRB about the use of a custom because physicians or institutions may seek inform device in patients at their healthcare facility. IRBs may develop procedures for the use of custom devices to ensure that patient protect ion measures are thoughtfully carried out. 12

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