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fully accredited since 2006 Mitchell E. Parrish, JD, RAC, CIP Regulatory Attorney Reviewing Research Involving Medical Devices September 23 & 25, 2014
fully accredited since 2006
Mitchell E. Parrish, JD, RAC, CIP Regulatory Attorney
Reviewing Research Involving Medical Devices
September 23 & 25, 2014
• Recording & Slide Deck
• The webinar recording and slide deck will be posted on our website within 5 business days
• We will email you a link to view the recording as soon as it is available
• Feel free to share the link with your staff and/or colleagues
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WEBINAR HOUSEKEEPING
• ABOUT QUORUM REVIEW IRB
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ABOUT QUORUM REVIEW IRB
Accredited Fully accredited by AAHRPP through 2019
Fully compliant with FDA and OHRP requirements
Regulatory Leadership
30-member Regulatory department including attorneys and specialists providing guidance and thought-leadership
International Reach
Boards available for the review of U.S. and Canadian studies – can review for GCP and ICH internationally
Strong Framework One 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
• 15 Board meetings each week
• 24-hour site turnaround, 36-hour amendment review, and same day site changes
• One time CV and audit documentation submission
• Support available 8am-8pm ET
• Dedicated Study Manager
• Industry-leading legal team
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THE QUORUM ADVANTAGE
• Secure portal with SmartForms™, status reports, and approval documents – and now Live Chat with our support teams
• Customized Phase I and Expeditable Research processes
• Flexible, customized process for Academic Medical Centers
– Over 1,000 Institutions work with Quorum
• 100% Quality Control on all documents
• Commitment to 6 Sigma Process Analysis
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THE QUORUM ADVANTAGE
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Upcoming Conference
October 24, 2014 • Attend live at Boston Marriott
Cambridge or virtually via webcast
• Discussion 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]
Quorum Review Regulatory Attorney Mitchell E. Parrish, JD, RAC, CIP
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ABOUT THE PRESENTER
IRB Experience Joined Quorum Review, Inc. in January 2010 CIP certification Regulatory Affairs Certification Member of Public Responsibility in
Medicine & Research (PRIM&R)
Legal Background Juris Doctor from University of Oregon Member of the Washington State Bar Association
(WSBA) Member of the Regulatory Affairs Professionals
Society (RAPS)
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Webinar Overview
• Part I: U.S. and Canadian Authorities & Definitions of Medical Devices
• Part II: IRB Review of Medical Devices Ethical Principles Regulatory Requirements Appropriate Documentation
• Part III: Special Considerations Combination Products Humanitarian Use Devices In Vitro Diagnostics Companion Diagnostics Adaptive Clinical Trials
• Summary
Part I: Authorities in
U.S. & Canada
Authorities
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• Medical Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is…
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or
• Intended 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 devices
• FDA 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)
Authorities (continued)
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• Food 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 Classifications • 21 CFR 50: Protection of Human Subjects • 21 CFR 56: Institutional Review Boards
• Office for Human Research Protections (OHRP) • 45 CFR 46: Protection of Human Subjects
• International Organization for Standardization (ISO) • ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects—Good Clinical
Practice
Authorities
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• Medical 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, OR
• Restoring, correcting or modifying a body function or the body structure of human beings or animals, OR
• The diagnosis of pregnancy, OR
• Care during pregnancy and after birth*
• Health Canada Therapeutic Products Directorate, Medical Devices Bureau (MDB): Responsible for Health Canada regulated medical devices
Citation: *Section 2 of the Canadian Food and Drugs Act
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• Health Canada • Medical Device Regulations (SOR/98-282)
- Part 3: Medical Devices for Investigational Testing Involving Human Subjects [ITA]
- Schedule 1: Classification Rules for Medical Devices
• Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada
• 2nd 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 Subjects—Good Clinical Practice
Authorities (continued)
Part II: IRB Review of
Medical Devices
IRB Review of Medical Devices
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No matter what the device, the IRB will always ensure its review addresses:
1. Ethical Principles 2. Regulatory
Requirements 3. Appropriate
Documentation for the device
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Ethical Principles
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IRB Review of Medical Devices Ethical Principles
Belmont Report •Respect for Persons: Uphold autonomy and protect vulnerable populations
i.e. informed consent
•Beneficence: Maximize benefits and minimize harms
i.e. risk to benefit ratio
•Justice: ensure equal distribution of burdens and benefits
i.e. selection of subjects
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IRB Review of Medical Devices Ethical Principles
Declaration of Helsinki • While there are multiple principles in the Declaration, General
Principle 7 presents the overarching theme of the document − “Medical research is subject to ethical standards that promote and ensure
respect for all human subjects and protect their health and rights”
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IRB Review of Medical Devices Unique Ethical Considerations
Sham Surgeries
• A problem with device studies is how to determine how much of an effect is from the device as opposed to placebo effect
• In 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 effect
Citation: * 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):988–992.
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IRB Review of Medical Devices Unique Ethical Considerations
Sham Surgery Dilemma
Sham surgeries involve no benefit and may carry risks, so how do you rectify this with . . .
• Belmont Report: “Do no harm”
• Declaration 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”
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IRB Review of Medical Devices Unique Ethical Considerations
Sham Surgery Example Blood Pressure Device - Renal Denervation (RDN)
• RDN = A minimally invasive, endovascular catheter based procedure using radiofrequency ablation aimed at treating resistant hypertension. By applying radio-frequency 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 decreased
• RDN (Simplified) = Zapping of the renal artery with electric energy to lower blood pressure
• Study: A new medical device is being tested for use in RDN • Group 1: Goes through the procedure and tests the investigational device
• Group 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
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IRB Review of Medical Devices Unique Ethical Considerations
Example: Ventricular Assist Device
Ongoing Care and Removal of the Device For studies involving an implantable or long term device
• What 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 device’s servicing, modifications, replacement, etc.?
• What happens in the case that the device must be removed and who pays for that procedure?
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Regulatory Requirements
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IRB Review of Medical Devices Regulatory Requirements
• Risks are minimized
• Risks are reasonable in relation to anticipated benefits
• Selection of subjects is equitable
• Informed Consent
• Adequate data monitoring to ensure the safety of subjects
• Adequate privacy and confidentiality protections
• Additional safeguards to protect the rights and welfare of vulnerable populations
Citation: FDA regulation 21 CFR 56.111
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IRB Review of Medical Devices Regulatory Requirements for Pediatric Research
• 50.51 Research not involving greater than minimal risk
• 50.52 Research involving greater than minimal risk but presenting the prospect of direct benefit
• 50.53 Research involving greater than minimal risk and no prospect of direct benefit, but likely to yield generalizable knowledge about the subject’s disorder or condition
• Greater than minimal risk here actually means “minor increase over minimal”
• 50.54 Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
• FDA commissioner determination required for this category
Citation: FDA regulation 21 CFR 50
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IRB Review of Medical Devices Regulatory Requirements • Risks 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
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IRB Review of Medical Devices Unique Regulatory Considerations
Appropriate Investigators
• As required of sponsors in the U.S.* and in Canada,** the IRB must evaluate each investigator’s qualifications:
• education • training • expertise • experience
• IRB’s duty to evaluate investigators is especially important with device trials. For example, consider:
• Studies involving a surgical procedure • Studies involving complicated devices
Citation: * FDA regulation 21 CFR 812.43(a); **Health Canada regulation SOR/98-282, Part 3, Sec. 81
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IRB Review of Medical Devices Unique Regulatory Considerations
Charging Participants for the Medical Device
FDA Information Sheet: Charging For Investigational Products “The 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 device
• If 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)
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Documentation Appropriate
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 documentation
Nonetheless, ensuring appropriate documentation is an IRB function
• Appropriate documentation from authorities provides additional assurance to the IRB that the research device’s risk to benefit ratio is acceptable − U.S. = Class 1, PMA approval, 510(k) clearance, IDE, NSR, Exempt
− Canada = Class 1, Licensed (a.k.a. approved), ITA
• Association 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 authorities − Ex. 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 IRB
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IRB Review of Medical Devices Appropriate Documentation
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IRB Review of Medical Devices Appropriate Documentation
FDA Warning Letter to Coast IRB
• Failed to determine applicability of 21 CFR 812 device regulations
• Failed 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 determination
Summary: Failed by approving the research without ensuring the study device had appropriate device documentation (specifically, an IDE from the FDA)
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IRB Review of Medical Devices Appropriate Documentation
The IRB must have documentation for each device that is the focus of the research
o Ex. Study comparing efficacy of two investigational devices
The IRB must have documentation for both devices!
o Ex. Study comparing efficacy of an investigational device to a currently marketed device
The IRB must have documentation for both devices!
o Ex. Phase III study of an investigational drug for Alzheimer’s that utilizes a marketed MRI device to assess the drug’s effect on slowing the loss of brain cells associated with the disease
The IRB does not require documentation for the MRI device!
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IRB Review of Medical Devices Appropriate Documentation
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IRB 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 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)
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IRB 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 Classification • The 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 type
• Generally, any person may request to know the class of their device from the FDA
De Novo Review: The FDA may grant de novo review and determine a device is Class I if
• A 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 effectiveness
Other documentation from the FDA
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IRB 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.
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IRB Review of Medical Devices Step 2: Documentation?
510(k) Clearance Letter and Indications for Use
• 510(k) number ex. “K123456”
• http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/default.htm
Protocol and associated documents that support the device in the study is being used according to its cleared indications
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IRB 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.
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IRB Review of Medical Devices Step 3: Documentation?
PMA Approval Letter (which contains the Indications for Use)
• PMA number ex. “P123456”
• http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/default.htm
Protocol and associated documents that support the device in the study is being used according to its approved indications
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IRB 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 market
To 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.
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IRB Review of Medical Devices Step 4: Documentation?
IDE Approval Letter
• IDE number ex. “G123456”
• Not available online. Must request from the Sponsor.
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IRB 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; or • Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.*
Citation: * FDA regulation 21 CFR 812.3(m)
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IRB 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 Sponsor’s assessment that the device is not a significant risk device
FDA risk assessment (i.e. documentation from the FDA agreeing that the device is NOT a significant risk device)
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IRB 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 noninvasive 2. does not require an invasive sampling procedure that presents significant risk 3. does not by design or intention introduce energy into a subject, and 4. 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)
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IRB 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 Sponsor’s assessment that the device is a diagnostic device
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IRB Review of Medical Devices Appropriate Documentation
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IRB 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)
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IRB 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 Canada
Citation: * Health Canada regulations SOR/98-282 s. 6; SOR/98/282 Schedule 1
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IRB 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 devices
• Similar to the FDA 510(k) process for Class III devices
• Similar to the FDA PMA process for Class IV devices
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IRB Review of Medical Devices Step 2: Documentation?
Health Canada Medical Device License
• License number ex. “No. 1234”
• http://webprod5.hc-sc.gc.ca/mdll-limh/index-eng.jsp
Protocol and associated documents that support that the device in the study is being used according to its licensed indications
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IRB 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 trial
• To 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
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IRB Review of Medical Devices Step 3: Documentation?
ITA Letter • Not available online. Must
request from the Sponsor.
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Considerations Special
Part III:
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Special Considerations: Combination Products
Combination Product - Drug/Device or Biologic/Device
• If 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 product’s Primary Mode of Action (PMO)
• PMO = Drug (ex. New injection device for administering a particular drug)
U.S. = Investigational New Drug (IND) number
Canada = No Objection Letter
• PMO = Biologic (ex. New injection device for administering a particular vaccine)
U.S. = Investigational New Drug (BB-IND) number
Canada = No Objection Letter
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Special Considerations: Humanitarian Use Device
Humanitarian 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 care
• Confirm device has a Humanitarian Device Exemption (HDE)
• Review and approve the use of the device at the specific facility in which it will be used
• Protocol? • Consent?
Citation: * FDA regulation 21 CFR 814 Subpart H
IRB duty if in using the HUD, research data is also being collected • Confirm device has a Humanitarian Device Exemption (HDE) • Review and approve the use of the device at the specific facility in
which it will be used • A research Protocol is required • Consent is required
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Special Considerations: Humanitarian Use Device (continued)
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Special Considerations: In Vitro Diagnostic Device
In 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 waiver
• However, the FDA may exercise enforcement discretion and not require informed consent if all of the following are true…
Citation: * FDA regulation 21 CFR 809.3(a); **45 CFR 46.116(d)
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Special 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 specimens
c) The specimens are not individually identifiable
d) 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 sponsor
e) The individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation
f) 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 information
g) 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
Companion Diagnostics
An in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product
• The 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 documentation
ex. Drug/Device = IND & 510(k) or PMA
ex. Biologic/Device = BB-IND & 510(k) or PMA
• Since 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
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Special Considerations: Companion Diagnostics
Citation: * http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm
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Special Considerations: Adaptive Trials
Adaptive Clinical Trials
A 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 sizes • shorter trial duration • salvaged successful portions of trials • increased efficiency
• Adaptive trials do not permit ad hoc changes. Rather, they permit design changes that are pre-specified and planned in advance
• These planned potential design changes are not protocol amendments that require prior IRB review
Specific device examples: Complicated devices involving software (MRI, CT Scans, Laser Surgery Tools, etc.)
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Summary • Know the authorities in place governing medical device research in the
U.S. and Canada
• Think of reviewing medical device research in terms of – applying ethical principles – ensuring compliance with regulatory requirements – obtaining appropriate documentation for the medical device(s)
• Consider those unique issues that arise with – Combination Products – Humanitarian Use Devices – In Vitro Diagnostics – Companion Diagnostics – Adaptive Trials
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Thank You for Attending!
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fully accredited since 2006
Mitchell E. Parrish, JD, RAC, CIP Regulatory Attorney
Reviewing Research Involving Medical Devices
