นายแพทย์ สหพล อนันต์นำเจริญ วิทยาลัยแพทยศาสตร์ พระมงกุฎเกล้า Medical Devices นายแพทย์ สหพล อนันต์นำเจริญ วิทยาลัยแพทยศาสตร์ พระมงกุฎเกล้า

safeguarding the rights, safety, and well-being of the research subjects Two primary protections people have for subject of research are Right risk benefit assessment scientific/social value? standard of care? 2. Valid informed consent information comprehension voluntariness

Medical Devices/Drug Drug: If the primary intended use of the product is achieved through chemical action or by being metabolized by the body Device: 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

Is The Product A Medical Device? Medical Device Definition an 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

* 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.

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 - K061542 plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick. LightTouch™ Non-invasive Cervical Cancer Detection

Access: FDA’s Center for Devices and Radiological Health (CDRH) Classification Database. Device Determination Officer, Office of Compliance

computer-driven weaning protocol: difficult weaning การศึกษาความสำเร็จของการหย่าเครื่องช่วยหายใจเปรียบเทียบระหว่างการใช้เครื่อง SmartCare/PS กับ การใช้ T-piece weaning computer-driven weaning protocol: difficult weaning การศึกษาเพื่อประเมินความปลอดภัยและประสิทธิภาพของการใช้ขดลวด เคลือบยา….ในการรักษาผู้ป่วยหลอดเลือดหัวใจตีบ การศึกษาความแม่นยำในการตรวจวินิจฉัย Human Papilloma Virus โดยวิธีตรวจหา DNA โดยใช้ Hybrid Capture II assay เปรียบเทียบกับการตรวจทางพยาธิวิทยา “safety and effectiveness of the new device”

Medical devices For marketing For investigation Premarket Notification (510k) 510(k) Exempt Devices Premarket Approval (PMA) For investigation Investigational Device Exemption (IDE): 21 CFR 812

Device Classification The Food and Drug Administration (FDA) has established classifications 1,700 different generic types of devices grouped them into 16 medical specialties Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

Device Classification classification is risk based the 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 risk Class III includes those with the greatest risk.

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.

IDE needed Significant risk device research Non-significant risk device research IRB approval; after which the study is considered to have an IDE IRB disagrees and determines that the device poses a significant risk, the sponsor must report this finding to FDA within five working days Clinical investigations of devices where safety and effectiveness data are collected New intended use of an approved device

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?

Is the device SR or NSR? Significant risk device Intended as an implant and presents a potential serious risk to the health, safety, or welfare of a subject e.g. pace maker, deep brain stimulators, implanted fecal incontinence device Implantable Middle Ear Hearing Device

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 subject e.g. respirators, dialysis machines

Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential serious risk to the health, safety, or welfare of a subject Otherwise presents a potential for serious risk to the health safety or welfare of the subject e.g. kit, dna detection, human papillomavirus, tissue adhesives for use in neurosurgery, bronchial tube, sutures.

Does it raise new questions of safety and effectiveness? Device classification depends on the intended use of the device and indications for use Approved device: New intended use New device: new materials or design used in approved devices New device: new indication

Does it raise new questions of safety and effectiveness?: NO 1. Approved devices used in accordance with labeling 2. Only using the device to address the research question – not safety and effectiveness Stapled Hemorrhoidectomy versus Conventional Excision Hemorrhoidectomy for Acute Hemorrhoidal Crisis 3. Testing of a minor modification, 4. Testing of a combination of approved devices

Does it raise new questions of safety and effectiveness?: NO A diagnostic device if it complies with the labeling requirements 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; and d. is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure;

Does it raise new questions of safety and effectiveness?: YES Clinical investigations of devices where safety and effectiveness data are collected Significant risk device research New intended use of an approved device Different age population New disease or condition Different body placement Changing from ‘treatment’ to ‘prevention’ for the same disease 4. Also, new materials or design used in approved devices

All medical devices must 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.

Physician should - use firm scientific rationale and sound medical evidence use in accordance with labeling well informed about the product monitoring of the study required records and reports.

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.

Device Class and Regulatory Controls Class I General Controls 510(k) Exempt Devices Without Exemptions (510k) Class II General Controls and Special Controls Without Exemptions (510k) Class III General Controls and Premarket Approval (PMA)

A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and has the same technological characteristics as the predicate; or

A device is substantially equivalent has the same intended use as the predicate; and has different technological characteristics and the information submitted to FDA; does not raise new questions of safety and effectiveness; and demonstrates that the device is at least as safe and effective as the legally marketed device.

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 program submit 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

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.

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.

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 consent Monitoring - All investigations must be properly monitored to protect the human subjects and assure compliance with approved protocols under

Prohibitions - Commercialization, promotion, and misrepresentation of an investigational device and prolongation of the study are prohibited Records and Reports - Sponsors and investigators are required to maintain specified records and make reports to investigators, IRBs, and FDA

Premarket Approval 1. ครื่องมือแพทย์ที่ต้องมีใบอนุญาต ได้แก่ ถุงยางอนามัย ถุงมือยางสำหรับการตรวจโรค ถุงมือยางสำหรับการศัลยกรรม กระบอกฉีดยาผ่านผิวหนังปราศจากเชื้อชนิดใช้ครั้งเดียว กระบอกฉีดยาอินซูลินปราศจากเชื้อชนิดใช้ครั้งเดียว ชุดตรวจการติดเชื้อเอชไอวีเพื่อวินิจฉัยโรค

Premarket Notification 2. เครื่องมือแพทย์ที่ต้องแจ้งรายการละเอียด เครื่องมือแพทย์กลุ่มนี้ ผู้ประกอบการผลิต นำเข้า หรือขายต้องแจ้งรายการละเอียดต่อเลขาธิการคณะกรรมการอาหารและยา ตามกฎกระทรวง ฉบับที่ 4 (พ.ศ. 2533) เครื่องมือแพทย์ในกลุ่มนี้ได้แก่ 2.1 ชุดตรวจการติดเชื้อเอชไอวี เพื่อวัตถุประสงค์อื่น : ประกาศกระทรวงสาธารณสุข ( ฉบับที่18 ) พ.ศ. 2538 2.2 เครื่องใช้หรือผลิตภัณฑ์ที่ใช้เพื่อกายภาพบำบัด : ประกาศกระทรวงสาธารณสุข (ฉบับ ที่ 19) พ.ศ. 2539 2.3 เครื่องตรวจวัดระดับหรือปริมาณแอลกอฮอล์ในร่างกาย : ประกาศกระทรวงสาธารณสุข (ฉบับที่ 22) พ.ศ. 2540 2.4 เต้านมเทียมซิลิโคนใช้ฝังในร่างกาย : ประกาศกระทรวงสาธารณสุข (ฉบับที่ 23) พ.ศ. 2540

3. เครื่องมือแพทย์นำเข้าทั่วไป เครื่องมือแพทย์ที่ไม่จัดเข้าข่ายเครื่องมือแพทย์ที่ต้องมีใบอนุญาต หรือที่ต้องแจ้งรายการละเอียด จัดเป็นเครื่องมือแพทย์ทั่วไปที่ผู้ผลิต ผู้นำเข้าหรือผู้ขาย ไม่ต้องรับใบอนุญาตหรือแจ้งรายการละเอียด แต่ผู้ประกอบการนำเข้าต้องแสดงหนังสือรับรองการขายเครื่องมือแพทย์ในประเทศผู้ผลิต ซึ่งออกโดยทางราชการหรือ สถาบันเอกชนที่ทางราชการของประเทศนั้นรับรองและ ผ่านการตรวจสอบจากคณะกรรมการอาหารและยาแล้ว แสดงต่อพนักงานเจ้าหน้าที่ ณ ด่านศุลกากรตามประกาศ กระทรวงสาธารณสุข ฉบับที่ 34 (พ.ศ. 2549)

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.

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.

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.

Monitoring investigation (a) Securing compliance investigator 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.

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.

Thank you for your attention