2 safeguarding the rights, safety, and well-being of the research subjects Two primary protections people have for subject of research areRight risk benefit assessmentscientific/social value?standard of care?2. Valid informed consentinformationcomprehensionvoluntariness
3 Medical Devices/DrugDrug: If the primary intended use of the product is achieved through chemical action or by being metabolized by the bodyDevice: does not achieve any of it's primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes
4 Is The Product A Medical Device? Medical Device Definitionan instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:* recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,* intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
5 * which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals.* which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
6 GeneSearch™ BLN Test Kit - P060017 metastases larger than 0.2 mm in nodal tissue removed from biopsies of breast cancer patients.Binax Now® Malaria Test - K061542plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick.LightTouch™ Non-invasive Cervical Cancer Detection
8 Access: FDA’s Center for Devices and Radiological Health (CDRH) Classification Database. Device Determination Officer, Office of Compliance
9 computer-driven weaning protocol: difficult weaning การศึกษาความสำเร็จของการหย่าเครื่องช่วยหายใจเปรียบเทียบระหว่างการใช้เครื่องSmartCare/PS กับ การใช้ T-piece weaningcomputer-driven weaning protocol: difficult weaningการศึกษาเพื่อประเมินความปลอดภัยและประสิทธิภาพของการใช้ขดลวดเคลือบยา….ในการรักษาผู้ป่วยหลอดเลือดหัวใจตีบการศึกษาความแม่นยำในการตรวจวินิจฉัย Human Papilloma Virusโดยวิธีตรวจหา DNA โดยใช้ Hybrid Capture II assayเปรียบเทียบกับการตรวจทางพยาธิวิทยา“safety and effectiveness of the new device”
10 Medical devices For marketing For investigation Premarket Notification (510k)510(k) Exempt DevicesPremarket Approval (PMA)For investigationInvestigational Device Exemption(IDE): 21 CFR 812
12 Device Classification The Food and Drug Administration (FDA) has established classifications1,700 different generic types of devicesgrouped them into 16 medical specialtiesEach of these generic types of devices is assigned toone of three regulatory classes based on the level ofcontrol necessary to assure the safety andeffectiveness of the device.
13 Device Classification classification is risk basedthe risk the device poses to the patient and/or the user is a major factor in the class it is assigned.Class I includes devices with the lowest riskClass III includes those with the greatest risk.
17 Investigational Device Exemption (IDE) IDE: allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.
18 IDE needed Significant risk device research Non-significant risk device researchIRB approval; after which the study is considered to have an IDEIRB disagrees and determines that the device poses a significant risk, the sponsor must report this finding to FDA within five working daysClinical investigations of devices where safety and effectiveness data are collectedNew intended use of an approved device
19 Medical devices IRB must know three basic things Does the study involve a device?Is the device SR or NSR?Does it raise new questions of safety and effectiveness?
20 Is the device SR or NSR? Significant risk device Intended as an implant andpresents a potential seriousrisk to the health, safety, or welfareof a subjecte.g. pace maker,deep brain stimulators,implanted fecal incontinence deviceImplantable Middle Ear Hearing Device
21 Is purported or represented to be for a use in supporting or sustaining human life and presents a potential serious risk to the health, safety, or welfare of a subjecte.g. respirators, dialysis machines
22 Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human healthand presents a potential serious risk to the health, safety, or welfare of a subjectOtherwise presents a potential for serious risk to the health safety or welfare of the subjecte.g. kit, dna detection, human papillomavirus, tissue adhesives for use in neurosurgery, bronchial tube, sutures.
23 Does it raise new questions of safety and effectiveness? Device classification depends onthe intended use of the device andindications for useApproved device: New intended useNew device: new materials or design used in approved devicesNew device: new indication
24 Does it raise new questions of safety and effectiveness?: NO 1. Approved devices used in accordance with labeling2. Only using the device to address the researchquestion – not safety and effectivenessStapled Hemorrhoidectomy versus Conventional Excision Hemorrhoidectomy for Acute Hemorrhoidal Crisis3. Testing of a minor modification,4. Testing of a combination of approved devices
25 Does it raise new questions of safety and effectiveness?: NO A diagnostic device if it complies with the labelingrequirements in §809.10(c) and if the testing:a. is noninvasive;b. does not require an invasive sampling procedure that presents significant risk;c. does not by design or intention introduce energy into a subject; andd. is not used as a diagnostic procedure without confirmation by another medicallyestablished diagnostic product or procedure;
26 Does it raise new questions of safety and effectiveness?: YES Clinical investigations of devices where safety and effectiveness data are collectedSignificant risk device researchNew intended use of an approved deviceDifferent age populationNew disease or conditionDifferent body placementChanging from ‘treatment’ to ‘prevention’ forthe same disease4. Also, new materials or design used in approved devices
27 All medical devicesmust be manufactured under a quality assurance program,be suitable for the intended use,be adequately packaged and properly labeled,have establishment registration and device listing forms on file with the FDA.
28 Physician should- use firm scientific rationale and sound medical evidenceuse in accordance with labelingwell informed about the productmonitoring of the studyrequired records and reports.
29 Marketing Substantial Equivalence (SE) A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device.Substantial equivalence (SE) means that the new device is at least as safe and effective as the predicate.
30 Device Class and Regulatory Controls Class I General Controls510(k) Exempt DevicesWithout Exemptions (510k)Class II General Controls and Special ControlsWithout Exemptions (510k)Class III General Controls and Premarket Approval (PMA)
31 A device is substantially equivalent if, in comparison to a predicate it:has the same intended use as the predicate; andhas the same technological characteristics as the predicate; or
32 A device is substantially equivalent has the same intended use as the predicate; andhas different technological characteristics and the information submitted to FDA;does not raise new questions of safety and effectiveness; anddemonstrates that the device is at least as safe and effective as the legally marketed device.
33 In order to conduct a significant risk device study submit a complete IDE application to FDA for review and obtain FDA approval of the IDE;device must be manufactured under a quality assurance programsubmit the investigational plan and report of prior investigations to the IRB at each institution where the investigation is to be conducted for review and approval; and
34 select qualified and obtain signed investigator agreements. an IDE application is considered approved 30 days after it has been received by FDA, unless FDA otherwise informs the sponsor prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.
35 Labeling - The device must be labeled in accordance with the labeling provisions of the IDE regulation and must bear the statement "CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use."Distribution - Investigational devices can only be distributed to qualified investigators.
36 Informed Consent - Each subject must be provided with and sign an informed consent form before being enrolled in the study. Protection of Human Subjects, contains the requirements for obtaining informed consentMonitoring - All investigations must be properly monitored to protect the human subjects and assure compliance with approved protocols under
37 Prohibitions - Commercialization, promotion, and misrepresentation of an investigational device and prolongation of the study are prohibitedRecords and Reports - Sponsors and investigators are required to maintain specified records and make reports to investigators, IRBs, and FDA
44 Investigational plan(a)Purpose. The name and intended use of the device and the objectives and duration of the investigation.(b)Protocol. A written protocol describing the methodology to be used and an analysis of the protocol demonstrating that the investigation is scientifically sound.(c)Risk analysis. A description and analysis of all increased risks to which subjects will be exposed by the investigation; the manner in which these risks will be minimized; a justification for the investigation; and a description of the patient population, including the number, age, sex, and condition.
45 Investigational plan(d)Description of device. A description of each important component, ingredient, property, and principle of operation of the device and of each anticipated change in the device during the course of the investigation.(e)Monitoring procedures. The sponsor's written procedures for monitoring the investigation and the name and address of any monitor.(f)Labeling. Copies of all labeling for the device.
46 Investigational plan((g)Consent materials. Copies of all forms and informational materials to be provided to subjects to obtain informed consent.(h) Additional records and reports. A description of records and reports that will be maintained on the investigation in addition to those prescribed in subpart G.
47 Monitoring investigation (a) Securing complianceinvestigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either secure compliance, or discontinue shipments of the device to the investigator and terminate the investigator's participation in the investigation. A sponsor shall also require such an investigator to dispose of or return the device, unless this action would jeopardize the rights, safety, or welfare of a subject.
48 Monitoring investigation (b)Unanticipated adverse device effects.(1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect.(2) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon as possible. Termination shall occur not later than 5 working days after the sponsor makes this determination and not later than 15 working days after the sponsor first received notice of the effect.