Webinar: Reviewing Research Involving Medical Devices

• 1. fully accredited since 2006Mitchell E. Parrish, JD, RAC, CIP Regulatory AttorneyReviewing ResearchInvolving Medical DevicesSeptember 23 & 25, 2014

2. 2 3. Recording & Slide DeckThe webinar recording and slide deck will be posted on our website within 5 business daysWe will email you a link to view the recording as soon as it is availableFeel free to share the link with your staff and/or colleagues3WEBINAR HOUSEKEEPING 4. ABOUT QUORUM REVIEW IRB4ABOUT QUORUM REVIEW IRBAccreditedFully accredited by AAHRPP through 2019Fully compliant with FDA and OHRP requirementsRegulatory Leadership30-member Regulatory department including attorneys and specialists providing guidance and thought-leadershipInternational ReachBoards available for the review of U.S. and Canadian studies can review for GCP and ICH internationallyStrong FrameworkOne of the largest IRBs in the U.S. with nearly 200 employees Quorum Review is the ONLY equivalently sized IRB not owned by Venture Capital 5. 15 Board meetings each week24-hour site turnaround, 36-hour amendment review, and same day site changesOne time CV and audit documentation submissionSupport available 8am-8pm ETDedicated Study ManagerIndustry-leading legal team5THE QUORUM ADVANTAGE 6. Secure portal with SmartForms, status reports, and approval documents and now Live Chat with our support teamsCustomized Phase I and Expeditable Research processesFlexible, customized process for Academic Medical CentersOver 1,000 Institutions work with Quorum100% Quality Control on all documentsCommitment to 6 Sigma Process Analysis6THE QUORUM ADVANTAGE 7. 7Upcoming ConferenceOctober 24, 2014Attend live at Boston Marriott Cambridge or virtually via webcastDiscussion will cover best practices to collect, store, and use large data and biospecimen collections (with IRB approval)Learn more via the advertisement on QuorumReview.com or email us: [email protected] 8. Quorum Review Regulatory Attorney Mitchell E. Parrish, JD, RAC, CIP8ABOUT THE PRESENTERIRB ExperienceJoined Quorum Review, Inc. in January 2010CIP certificationRegulatory Affairs CertificationMember of Public Responsibility in Medicine & Research (PRIM&R)Legal BackgroundJuris Doctor from University of OregonMember of the Washington State Bar Association (WSBA)Member of the Regulatory Affairs Professionals Society (RAPS) 9. 9Webinar OverviewPart I: U.S. and Canadian Authorities & Definitions of Medical DevicesPart II: IRB Review of Medical DevicesEthical PrinciplesRegulatory RequirementsAppropriate DocumentationPart III: Special ConsiderationsCombination ProductsHumanitarian Use DevicesIn Vitro DiagnosticsCompanion DiagnosticsAdaptive Clinical TrialsSummary 10. Part I:Authorities inU.S. & Canada 11. Authorities 11Medical Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which isIntended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, orIntended to affect the structure or any function of the body AND does not achieve its primary intended purposes through chemical action within the body AND which is not dependent upon being metabolized for the achievement of its primary intended purposes*FDA Center for Devices and Radiological Health (CDRH): Responsible for FDA regulated medical devicesFDA Center for Biologics Evaluation and Research (CBER): Responsible for FDA regulated medical devices related to blood and cellular products**Citation: * Section 201(h) of the U.S. Federal Food, Drug, and Cosmetic Act(FD&C); ** FDA Intercenter Agreement (31 October 1991) 12. Authorities (continued) 12Food and Drug Administration (FDA)21 CFR 807: Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices- Subpart E: Premarket Notification Procedures [510(k)]21 CFR 812: Investigational Device Exemptions [IDE]21 CFR 814: Premarket Approval of Medical Devices- Subpart B: Premarket Approval Application [PMA]- Subpart H: Humanitarian Use Devices [HUD]21 CFR 862-892: Medical Device Classifications21 CFR 50: Protection of Human Subjects21 CFR 56: Institutional Review BoardsOffice for Human Research Protections (OHRP)45 CFR 46: Protection of Human SubjectsInternational Organization for Standardization (ISO)ISO 14155:2011: Clinical Investigation of Medical Devices for Human SubjectsGood Clinical Practice 13. Authorities 13Medical Device: Any article, instrument, apparatus or contrivance, including any component, part of accessory thereof, manufactured, sold or represented for use in:The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, ORRestoring, correcting or modifying a body function or the body structure of human beings or animals, ORThe diagnosis of pregnancy, ORCare during pregnancy and after birth*Health Canada Therapeutic Products Directorate, Medical Devices Bureau (MDB): Responsible for Health Canada regulated medical devicesCitation: *Section 2 of the Canadian Food and Drugs Act 14. 14Health CanadaMedical Device Regulations (SOR/98-282)- Part 3: Medical Devices for Investigational Testing Involving Human Subjects [ITA]- Schedule 1: Classification Rules for Medical DevicesCanadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada2nd Edition, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)International Organization for Standardization (ISO)ISO 14155:2011 - Clinical Investigation of Medical Devices for Human SubjectsGood Clinical PracticeAuthorities (continued) 15. Part II:IRB Review ofMedical Devices 16. IRB Review of Medical Devices 16No matter what the device, the IRB will always ensure its review addresses:1.Ethical Principles2.Regulatory Requirements3.Appropriate Documentation for the device 17. 17EthicalPrinciples 18. 18IRB Review of Medical Devices Ethical PrinciplesBelmont ReportRespect for Persons: Uphold autonomy and protect vulnerable populationsi.e. informed consentBeneficence: Maximize benefits and minimize harmsi.e. risk to benefit ratioJustice: ensure equal distribution of burdens and benefitsi.e. selection of subjects 19. 19IRB Review of Medical Devices Ethical PrinciplesDeclaration of HelsinkiWhile there are multiple principles in the Declaration, General Principle 7 presents the overarching theme of the documentMedical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights 20. 20IRB Review of Medical Devices Unique Ethical ConsiderationsSham SurgeriesA problem with device studies is how to determine how much of an effect is from the device as opposed to placebo effectIn device studies involving a surgical procedure, the placebo response may mirror that seen for other therapeutic interventions, accounting for up to 35% of the response*Therefore, as with drug studies, it can be necessary to design clinical trials using a sham surgery control that equalizes the placebo effectCitation: * Freeman TB, Vawter DE, Leaverton PE, Godbold JH, Hauser RA, Goetz CG, Olanow CW. Use of placebo surgery in controlled trials of a cellular-based therapy for Parkinson's disease. N Engl J Med. 1999;341(13):988992. 21. 21IRB Review of Medical Devices Unique Ethical ConsiderationsSham Surgery DilemmaSham surgeries involve no benefit and may carry risks, so how do you rectify this with . . .Belmont Report: Do no harmDeclaration of Helsinki: While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects 22. 22IRB Review of Medical Devices Unique Ethical ConsiderationsSham Surgery ExampleBlood Pressure Device - Renal Denervation (RDN)RDN = A minimally invasive, endovascular catheter based procedure using radiofrequency ablation aimed at treating resistant hypertension. By applying radiofrequency pulses to the renal arteries, the nerves in the vascular wall can be denuded of nerve endings. This causes reduction of renal sympathetic afferent and efferent activity and blood pressure can be decreasedRDN (Simplified) = Zapping of the renal artery with electric energy to lower blood pressureStudy: A new medical device is being tested for use in RDNGroup 1: Goes through the procedure and tests the investigational deviceGroup 2: Goes through a sham procedure only, which involves a non-therapeutic incision. Risks from the procedure are bleeding, infection, antibiotic treatment to prevent infection, and the risk of anesthesia 23. 23IRB Review of Medical Devices Unique Ethical ConsiderationsExample: Ventricular Assist DeviceOngoing Care and Removal of the DeviceFor studies involving an implantable or long term deviceWhat ongoing monitoring and care is provided?What training on the device is provided to participants and their family or caregiver?What is the associated cost of the device and who pays for the devices servicing, modifications, replacement, etc.?What happens in the case that the device must be removed and who pays for that procedure? 24. 24RegulatoryRequirements 25. 25IRB Review of Medical Devices Regulatory RequirementsRisks are minimizedRisks are reasonable in relation to anticipated benefitsSelection of subjects is equitableInformed ConsentAdequate data monitoring to ensure the safety of subjectsAdequate privacy and confidentiality protectionsAdditional safeguards to protect the rights and welfare of vulnerable populationsCitation: FDA regulation 21 CFR 56.111 26. 26IRB Review of Medical Devices Regulatory Requirements for Pediatric Research50.51 Research not involving greater than minimal risk50.52 Research involving greater than minimal risk but presenting the prospect of direct benefit50.53 Research involving greater than minimal risk and no prospect of direct benefit, but likely to yield generalizable knowledge about the subjects disorder or conditionGreater than minimal risk here actually means minor increase over minimal50.54 Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of childrenFDA commissioner determination required for this categoryCitation: FDA regulation 21 CFR 50 27. 27IRB Review of Medical Devices Regulatory RequirementsRisks are minimized (TCPS 2, Article 11.1, 11.4)Risks are reasonable in relation to anticipated benefits (TCPS 2, Article 11.1, 11.4)Selection of subjects is equitable (TCPS 2, Chapter 4)Informed Consent (TCPS 2, Chapter 3)Adequate data monitoring to ensure the safety of subjects (TCPS 2, Article 11.7, 11.8)Adequate privacy and confidentiality protections (TCPS 2, Chapter 5)Additional safeguards to protect the rights and welfare of vulnerable populations (throughout TCPS 2)Citation: TCPS 2 28. 28IRB Review of Medical Devices Unique Regulatory ConsiderationsAppropriate InvestigatorsAs required of sponsors in the U.S.* and in Canada,** the IRB must evaluate each investigators qualifications:educationtrainingexpertiseexperienceIRBs duty to evaluate investigators is especially important with device trials. For example, consider:Studies involving a surgical procedureStudies involving complicated devicesCitation: * FDA regulation 21 CFR 812.43(a); **Health Canada regulation SOR/98-282, Part 3, Sec. 81 29. 29IRB Review of Medical Devices Unique Regulatory ConsiderationsCharging Participants for the Medical DeviceFDA Information Sheet: Charging For Investigational ProductsThe Investigational Device Exemption (IDE) regulations allow sponsors to charge for an investigational device, however, the charge should not exceed an amount necessary to recover the costs of manufacture, research, development, and handling of the investigational device [21 CFR 812.7(b)]. A sponsor justifies the proposed charges for the device in the IDE application, states the amount to be charged, and explains why the charge does not constitute commercialization [21 CFR 812.20(b)(8)]. FDA generally allows sponsors to charge investigators for investigational devices, and this cost usually is passed on to the subjects.Depending on the study, the IRB may not permit the research to charge participants for the deviceIf participants are billed for the device, it is crucial that the consent form clearly outline the costs that will be billed to participants or their insurance company*Citation: *FDA regulation 21 CFR 50.25(b)(3) 30. 30DocumentationAppropriate 31. FDA regulations, DHHS regulations, Health Canada regulations, and the TCPS 2 do not state that IRBs must review and ensure medical devices in the research trials they review have all appropriate regulatory documentationNonetheless, ensuring appropriate documentation is an IRB functionAppropriate documentation from authorities provides additional assurance to the IRB that the research devices risk to benefit ratio is acceptableU.S. = Class 1, PMA approval, 510(k) clearance, IDE, NSR, ExemptCanada = Class 1, Licensed (a.k.a. approved), ITAAssociation for the Accreditation of Human Research Protection Programs (AAHRPP) requires such function (Element I.7.A.)While the regulations in the U.S. and Canada are not explicit, be assured that the IRB is obligated to ensure documentation by regulatory authoritiesEx. FDA regulation 21 CFR 812.2 (discusses applicability of the IDE regulations to clinical trials and specifically mentions IRB)Ex. FDA Warning Letter to Coast IRB31IRB Review of Medical Devices Appropriate Documentation 32. 32IRB Review of Medical Devices Appropriate DocumentationFDA Warning Letter to Coast IRBFailed to determine applicability of 21 CFR 812 device regulationsFailed to determine if the apparently FDA cleared device was being used in accordance with its approved indications (and therefore was exempt from IDE requirements)Since device was not being approved in accordance with its indications (and was therefore not exempt) failed to make a risk determinationSummary: Failed by approving the research without ensuring the study device had appropriate device documentation (specifically, an IDE from the FDA) 33. 33IRB Review of Medical Devices Appropriate DocumentationThe IRB must have documentation for each device that is the focus of the researchoEx. Study comparing efficacy of two investigational devicesThe IRB must have documentation for both devices!oEx. Study comparing efficacy of an investigational device to a currently marketed deviceThe IRB must have documentation for both devices!oEx. Phase III study of an investigational drug for Alzheimers that utilizes a marketed MRI device to assess the drugs effect on slowing the loss of brain cells associated with the diseaseThe IRB does not require documentation for the MRI device! 34. 34IRB Review of Medical Devices Appropriate Documentation 35. 35IRB Review of Medical Devices Class I DeviceStep 1: Is the medical device a Class I Device?Class I: Low-risk devices (prescription sunglasses, elastic bandages, hand-held surgical instruments)Subject to general controls (i.e. exempt - the device can be marketed in the U.S)Class II: Intermediate-risk devices (blood glucose test systems, arterial catheters, infusion pumps)Subject to general controls and special controls (i.e. 510(k))Class III: High-risk devices (implantable pacemaker, HIV diagnostic tests) Subject to general controls, special controls, and pre-market approval (i.e. PMA) 36. 36IRB Review of Medical Devices Step 1: Documentation?The FDA regulation indicating that the study device is Class I (21 CFR 862-892)513(g) of the FD&C Act: Request For ClassificationThe FDA may reclassify a device if the device is within a type of device that has been classified into Class I and the FDA found the device substantially equivalent to a device within such typeGenerally, any person may request to know the class of their device from the FDADe Novo Review: The FDA may grant de novo review and determine a device is Class I ifA 510(k) is submitted for the device first and the FDA determines that the device is not substantially equivalent to a predicate device, has a new intended use, or the device has technological characteristics that raise new questions of safety and effectivenessOther documentation from the FDA 37. 37IRB Review of Medical Devices 510(k) Clearance?Step 2: Does the medical device have 510(k) Clearance?Clearance: The FDA reviewed a premarket notification known as a 510(k) and cleared the device (i.e. the device can be marketed in the U.S.) To clear a device, the FDA must determine that the device is substantially equivalent to a predicate device in terms of use, safety, and effectiveness 38. 38IRB Review of Medical Devices Step 2: Documentation?510(k) Clearance Letter and Indications for Use510(k) number ex. K123456http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/default.htmProtocol and associated documents that support the device in the study is being used according to its cleared indications 39. 39IRB Review of Medical Devices PMA Approval?Step 3: Does the medical device have Pre-market Approval?Approval: The FDA reviewed a premarket approval application (PMA) for the device and approved the application (i.e. the device can be marketed in the U.S.)To approve a device, the FDA must determine that the device is safe and effective 40. 40IRB Review of Medical Devices Step 3: Documentation?PMA Approval Letter (which contains the Indications for Use)PMA number ex. P123456http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/default.htmProtocol and associated documents that support the device in the study is being used according to its approved indications 41. 41IRB Review of Medical Devices PMA Approval?Step 4: Does the medical device have an Investigational Device Exemption (IDE)?IDE: The FDA reviewed an IDE application and permits the device to be shipped lawfully within the U.S. for the purpose of conducting investigations of the device without complying with requirements of the FD&C Act that apply to cleared or approved devices currently on the marketTo approve an IDE, the FDA reviews the research protocol and device information, amongst other information, to determine if the research as described in the application can proceed 42. 42IRB Review of Medical Devices Step 4: Documentation?IDE Approval LetterIDE number ex. G123456Not available online. Must request from the Sponsor. 43. 43IRB Review of Medical Devices NSR?Step 5: Is the medical device a Non-Significant Risk (NSR) Device as used in the study?NSR: The sponsor determines, and the IRB makes an affirmative finding, that the device as used in the study is not a significant risk (SR) device. SR =Is intended as an implant;Is purported or represented to be for a use in supporting or sustaining human life;Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; orOtherwise presents a potential for serious risk to the health, safety, or welfare of a subject.*Citation: * FDA regulation 21 CFR 812.3(m) 44. 44IRB Review of Medical Devices Step 5: Documentation?An explanation from the sponsor supporting why the device is NOT a significant risk device as defined in 21 CFR 812.3(m)Information in the protocol and supporting documents that substantiates the Sponsors assessment that the device is not a significant risk deviceFDA risk assessment (i.e. documentation from the FDA agreeing that the device is NOT a significant risk device) 45. 45IRB Review of Medical Devices Exempt?Step 6: Is the medical device an EXEMPT device?EXEMPTION: The sponsor determines, and the IRB agrees, that the device is exempt from needing an IDE because it is a diagnostic device according to 21 CFR 812.2(c)(3). Diagnostic device =1.Is noninvasive2.does not require an invasive sampling procedure that presents significant risk3.does not by design or intention introduce energy into a subject, and4.is not used without confirmation of the diagnosis by another medically established diagnostic product or procedure*Citation: * FDA regulation 21 CFR 812.2(c)(3) 46. 46IRB Review of Medical Devices Step 6: Documentation?An explanation from the Sponsor supporting why the device is a diagnostic device as defined in 21 CFR 812.2(c)(3)Information in the protocol and supporting documents that substantiates the Sponsors assessment that the device is a diagnostic device 47. 47IRB Review of Medical Devices Appropriate Documentation 48. 48IRB Review of Medical Devices Class I Device?Step 1: Is the medical device a Class I Device?Class I: Low-risk devices (prescription sunglasses, elastic bandages, hand-held surgical instruments)Subject to general requirements (i.e. Exempt the device can be marketed in Canada)Class II: Intermediate-risk devices (contact lenses, arterial catheters, blood reinfusion bags)Subject to general requirements and additional requirements (i.e. MDL)Class III: Intermediate-risk to high-risk devices (orthopedic implants, mammography X-ray systems) Subject to general requirements and additional requirements (i.e. MDL)Class IV: High-risk devices (implantable pacemakers, HIV diagnostic tests) Subject to general requirements and additional requirements (i.e. MDL) 49. 49IRB Review of Medical Devices Step 1: Documentation?The rules set out in SOR/98/282, Schedule 1 indicating that the study device is Class I*Other documentation from Health CanadaCitation: * Health Canada regulations SOR/98-282 s. 6; SOR/98/282 Schedule 1 50. 50IRB Review of Medical Devices Licensed?Step 2: Is the medical device licensed (i.e. approved)?Licensed: Health Canada reviewed a medical device license (MDL) application and approved the application (i.e. the device can be marketed in Canada)Similar to the FDA 510(k) process for Class II devicesSimilar to the FDA 510(k) process for Class III devicesSimilar to the FDA PMA process for Class IV devices 51. 51IRB Review of Medical Devices Step 2: Documentation?Health Canada Medical Device LicenseLicense number ex. No. 1234http://webprod5.hc-sc.gc.ca/mdll- limh/index-eng.jspProtocol and associated documents that support that the device in the study is being used according to its licensed indications 52. 52IRB Review of Medical Devices ITA?Step 3: Does the medical device have Investigational Testing Authorization (ITA)?ITA: Health Canada reviewed an ITA application and approved the testing of the device in the clinical trialTo approve an ITA application, Health Canada reviews the research protocol and device information, amongst other information, to determine if the research as described in the application can proceed 53. 53IRB Review of Medical Devices Step 3: Documentation?ITA LetterNot available online. Must request from the Sponsor. 54. 54ConsiderationsSpecialPart III: 55. 55Special Considerations: Combination ProductsCombination Product - Drug/Device or Biologic/DeviceIf the device in the U.S. or Canada is part of a combination product then the documentation that is required hinges on what is the products Primary Mode of Action (PMO)PMO = Drug (ex. New injection device for administering a particular drug)U.S. = Investigational New Drug (IND) numberCanada = No Objection LetterPMO = Biologic (ex. New injection device for administering a particular vaccine)U.S. = Investigational New Drug (BB-IND) numberCanada = No Objection Letter 56. 56Special Considerations: Humanitarian Use DeviceHumanitarian Use Device (HUD) A device intended to treat or diagnose diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year *IRB duty if HUD is being used solely for clinical careConfirm device has a Humanitarian Device Exemption (HDE)Review and approve the use of the device at the specific facility in which it will be usedProtocol?Consent?Citation: * FDA regulation 21 CFR 814 Subpart H 57. IRB duty if in using the HUD, research data is also being collectedConfirm device has a Humanitarian Device Exemption (HDE)Review and approve the use of the device at the specific facility in which it will be usedA research Protocol is requiredConsent is required 57Special Considerations: Humanitarian Use Device (continued) 58. 58Special Considerations: In Vitro Diagnostic DeviceIn Vitro Diagnostic Device (IVD)In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body*Unlike the DHHS regulations that permit the IRB to waive or alter informed consent for research that involves no more than minimal risk to subjects,** the FDA regulations do not have a provision for such waiverHowever, the FDA may exercise enforcement discretion and not require informed consent if all of the following are trueCitation: * FDA regulation 21 CFR 809.3(a); **45 CFR 46.116(d) 59. 59Special Considerations: In Vitro Diagnostic Device (continued)a)The investigation meets the IDE exemption criteria at 21 CFR 812.2(c) (3).b)The study uses leftover specimensc)The specimens are not individually identifiabled)The specimens may be accompanied by clinical information as long as this information does not make the specimen source identifiable to the investigator or any other individual associated with the investigation, including the sponsore)The individuals caring for the patients are different from and do not share information about the patient with those conducting the investigationf)The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal informationg)The study has been reviewed by an IRB*Citation: *Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable. FDA 2006 60. Companion DiagnosticsAn in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic productThe use of a companion diagnostic device with a particular therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product*Companion Diagnostics are NOT Combination Products. Both the drug or biologic and the corresponding device require their own separate documentationex. Drug/Device = IND & 510(k) or PMAex. Biologic/Device = BB-IND & 510(k) or PMASince the device provides essential information for the safe and effective use of the therapeutic product, the IRB should typically review the protocol for the device and therapeutic product together 60Special Considerations: Companion DiagnosticsCitation: * http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm 61. 61Special Considerations: Adaptive TrialsAdaptive Clinical TrialsA study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on interim analysis of data from subjects in the study.Goal = Have the trial adapt to emerging data (i.e. real time learning)smaller sample sizesshorter trial durationsalvaged successful portions of trialsincreased efficiencyAdaptive trials do not permit ad hoc changes. Rather, they permit design changes that are pre- specified and planned in advanceThese planned potential design changes are not protocol amendments that require prior IRB reviewSpecific device examples: Complicated devices involving software (MRI, CT Scans, Laser Surgery Tools, etc.) 62. 62SummaryKnow the authorities in place governing medical device research in the U.S. and CanadaThink of reviewing medical device research in terms ofapplying ethical principlesensuring compliance with regulatory requirementsobtaining appropriate documentation for the medical device(s)Consider those unique issues that arise withCombination ProductsHumanitarian Use DevicesIn Vitro DiagnosticsCompanion DiagnosticsAdaptive Trials 63. Webinar Follow-UpThe webinar recording and slide deck will be posted on our websiteWe will email you a link to view these items as they become availableWe value your opinion please take our SURVEY and provide us with feedback63 64. Connect with us!facebook.com/[email protected]/quorumreviewlinkedin.com/company/quorum-review 64 65. Thank You for Attending! 65 66. fully accredited since 2006Mitchell E. Parrish, JD, RAC, CIP Regulatory AttorneyReviewing ResearchInvolving Medical Devices